1 unchanged sentence
(a) Evaluation of Disclosure Controls and Procedures .
−Removed: The Company’s management, with the participation of the Company’s Chief Executive Officer (CEO), Chief Financial Officer (CFO) and Chief Accounting Officer (CAO), has evaluated the effectiveness of the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934) as of December 31, 2024.
+Added: The Company’s management, with the participation of the Company’s Chief Executive Officer (CEO), Chief Financial Officer (CFO) and Chief Accounting Officer (CAO), has evaluated the effectiveness of the Company’s disclosure controls
+Added: and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934) as of December 31, 2025.
Based on that evaluation, the Company’s management, including such officers, concluded that as of December 31, 2025 the Company’s disclosure controls and procedures were effective to provide reasonable assurance that information required to be disclosed by the Company in the reports that it files or submits under the Securities Exchange Act of 1934 is accumulated and communicated to the Company’s management, including the Chief Executive Officer, Chief Financial Officer and Chief Accounting Officer, to allow timely decisions regarding required disclosure and is recorded, processed, summarized, and reported within the time periods specified in the rules and forms of the Securities and Exchange Commission.
5 unchanged sentences
Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
−Removed: The Company acquired Sherlock Biosciences, Inc.
−Removed: and its wholly owned subsidiaries om December 19, 2024, and management excluded from its assessment of the effectiveness of the Company's internal control over financial reporting as of December 31, 2024, the acquired company representing approximately 4% of total assets, excluding intangible assets and goodwill related to the acquisition and 0% of total revenue of the Company as of and for the year ended December 31,2024.
−Removed: Management plans to fully integrate the operations of these businesses into the assessment of the effectiveness of the Company's internal control over financial reporting in 2025.
The effectiveness of the Company's internal control over financial reporting as of December 31, 2025 has been audited by GRANT THORNTON LLP, an independent registered public accounting firm, as stated in their report, which is included below.
5 unchanged sentences
Opinion on Internal Control Over Financial Reporting
−Removed: We have audited OraSure Technologies, Inc.
+Added: We have audited the internal control over financial reporting of OraSure Technologies, Inc.
(a Delaware corporation) and subsidiaries (the “Company”) as of December 31, 2025, based on criteria established in the 2013 Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”).
10 unchanged sentences
We believe that our audit provides a reasonable basis for our opinion.
−Removed: Our audit of, and opinion on, the Company’s internal control over financial reporting does not include the internal control over financial reporting of Sherlock Biosciences, Inc., a wholly-owned subsidiary, whose financial statements reflect total assets, excluding intangible assets and goodwill related to the acquisition, and revenues constituting 4 percent and 0 percent, respectively, of the related consolidated financial statement amounts as of and for the year ended December 31, 2024.
−Removed: As indicated in Management’s Report, Sherlock Biosciences, Inc.
−Removed: was acquired during 2024.
−Removed: Management’s assertion on the effectiveness of the Company’s internal control over financial reporting excluded internal control over financial reporting of Sherlock Biosciences, Inc.
Definition and Limitations of Internal Control Over Financial Reporting
9 unchanged sentences
Other Information.
−Removed: During the fourth quarter of the fiscal year ended December 31, 2024, no director of “officer” as defined in Rule 16a-1(f) under the Exchange Act adopted or terminated any Rule 10b5-1 trading plan or arrangements or any non-Rule 10b5-1 trading plan or arrangements, in both cases as defined in Item 408(a) of Regulation S-K.
+Added: The following table discloses any director or “officer” as defined in Rule 16a-1(f) under the Exchange Act who adopted or terminated any Rule 10b5-1 trading plan or arrangements or any non-Rule 10b5-1 trading plan or arrangements, in both cases as defined in Item 408(a) of Regulation S-K during the fourth quarter of the fiscal year ended December 31, 2025.
+Added: Name and Title Action Taken (Date of Action) Type of Trading Arrangement Nature of Trading Arrangement Duration or End Date Aggregate Number of Securities
+Added: Carrie Eglinton Manner President, Chief Executive Officer and Director
+Added: Adoption (November 29, 2025) Trading plan intended to satisfy the affirmative defense conditions of Securities Exchange Act Rule 10b5-1(c).
+Added: Purchase of the Company’s common stock pursuant to the terms of the plan.
+Added: Active through August 28, 2026 Up to $165,000 of shares of the Company’s common stock
+Added: Kenneth McGrath
+Added: Chief Financial Officer
+Added: Adoption (November 28, 2025) Trading plan intended to satisfy the affirmative defense conditions of Securities Exchange Act Rule 10b5-1(c).
+Added: Purchase of the Company’s common stock pursuant to the terms of the plan.
+Added: Active through August 28, 2026 Up to $165,000 of shares of the Company’s common stock
+Added: Other than as disclosed above, no other director or officer adopted or terminated any Rule 10b5-1 trading plan or arrangements or any non-Rule 10b5-1 trading plan or arrangements, in both cases as defined in Item 408(a) of Regulation S-K during the fourth quarter of the fiscal year ended December 31, 2025 .
Disclosure regarding Foreign Jurisdictions that Prevent Inspections
28 unchanged sentences
Paul Meister, solely in his capacity as representative of the securityholders of Sherlock Biosciences, Inc.
+Added: is incorporated by reference to Exhibit 2.1 to the Company’s Annual Report on form 10-K for the year ended December 31, 2024.
3.1.1 Certificate of Incorporation of OraSure Technologies, Inc.
5 unchanged sentences
dated May 16, 2024 is incorporated by reference to Exhibit 3.1 to the Company’s Periodic Report on Form 8-K filed on May 17, 2024.
−Removed: 3.2 Second Amended and Restated Bylaws of OraSure Technologies, as of May 9, 2023, is incorporated by referenced to Exhibit 3.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023.
+Added: 3.2 Third Amended and Restated Bylaws of OraSure Technologies, effective as of Au gust 5, 2025 , is incorporated by referenced to Exhibit 3.
+Added: 2 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025.
4.1 Description of Securities is incorporated by reference to Exhibit 4.1 to the Company’s Annual Report on Form 10-K for the year-ended December 31, 2019 .
32 unchanged sentences
2000 Stock Award Plan, Effective March 25, 2024, is incorporated by reference to Exhibit 10.1 to the Company's Current Report on Form 8-K filed May 17, 2024.*
+Added: 10.13 Amended and Restated OraSure Technologies, Inc.
+Added: 2000 Stock Award Plan, Effective March 2 4 , 2025, is incorporated by reference to Exhibit 10.1 to the Company's Current Report on Form 8-K filed May 14, 2025.
10.14 Form of Restricted Share Award Agreement (Executive Officers – Employment Agreements) is incorporated by reference to Exhibit 10.24 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2015.*
28 unchanged sentences
97.10 OraSure Technologies Inc.
−Removed: Compensation Recovery Policy is incorporated by reference to Exhibit 97.1 to the Co mpany's Annual Report on Form 10-K for the year ended December 31, 2023.
+Added: Compensation Recovery Policy is incorporated by reference to Exhibit 97.1 to the Company's Annual Report on Form 10-K for the year ended December 31, 2023.
101.INS Inline XBRL Instance Document
29 unchanged sentences
Michele Anthony
−Removed: ASPINALL Director
+Added: BOYD Director
GAGLIANO, M.D.
4 unchanged sentences
MCMAHON Director
−Removed: SHULKIN, M.D.
−Removed: Shulkin, M.D.
/s/Stefano Taucer
14 unchanged sentences
Opinion on the financial statements
−Removed: We have audited the accompanying consolidated balance sheet of OraSure Technologies, Inc.
−Removed: (a Delaware corporation) and subsidiaries (the “Company”) as of December 31, 2024, the related consolidated statements of operations, comprehensive income (loss), stockholders’ equity, and cash flows for the year ended December 31, 2024, and the related notes (collectively referred to as the “consolidated financial statements”).
−Removed: In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024, and the results of its operations and its cash flows for the year ended December 31, 2024, in conformity with accounting principles generally accepted in the United States of America.
+Added: We have audited the accompanying consolidated balance sheets of OraSure Technologies, Inc.
+Added: (a Delaware corporation) and subsidiaries (the “Company”) as of December 31, 2025 and 2024, the related consolidated statements of operations, comprehensive (loss) income, stockholders’ equity, and cash flows for each of the two years in the period ended December 31, 2025, and the related notes (collectively referred to as the “consolidated financial statements”).
+Added: In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2025, in conformity with accounting principles generally accepted in the United States of America.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (“PCAOB”), the Company’s internal control over financial reporting as of December 31, 2025, based on criteria established in the 2013 Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”), and our report dated March 9, 2026 expressed an unqualified opinion.
1 unchanged sentence
These consolidated financial statements are the responsibility of the Company’s management.
−Removed: Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audit.
+Added: Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits.
We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S.
federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
−Removed: We conducted our audit in accordance with the standards of the PCAOB.
+Added: We conducted our audits in accordance with the standards of the PCAOB.
Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud.
−Removed: Our audit included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks.
+Added: Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks.
Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
−Removed: Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements.
−Removed: We believe that our audit provides a reasonable basis for our opinion.
+Added: Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements.
+Added: We believe that our audits provide a reasonable basis for our opinion.
Critical audit matter
2 unchanged sentences
The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
−Removed: Fair value of the acquired in-process and research developed intangible asset and royalty contingent consideration in the Sherlock Biosciences, Inc.
−Removed: As further described in Note 14 to the consolidated financial statements, on December 19, 2024, the Company acquired Sherlock Biosciences, Inc.
+Added: Fair value of the royalty based contingent consideration from the Sherlock Biosciences, Inc.
+Added: As further described in Notes 2 and 13 to the consolidated financial statements, on December 19, 2024, the Company acquired Sherlock Biosciences, Inc.
("Sherlock"), pursuant to the terms of a merger agreement.
−Removed: The purchase consideration transferred in this transaction included contingent consideration, as defined under the merger agreement, related to, 1) achievement of a regulatory milestone associated with the acquired in-process research and development technology (“IPR&D technology”) intangible asset, and 2) royalty payments through December 31, 2034, representing a mid-single digit percentage of future revenues associated with the IPR&D technology intangible asset.
−Removed: Approximately $17.0 million of the initial purchase consideration was allocated to the IPR&D technology intangible asset.
−Removed: The estimated fair value of the royalty based contingent consideration was $7.0 million.
−Removed: We identified the fair value determinations of the IPR&D technology intangible asset and royalty based contingent consideration as a critical audit matter.
−Removed: The principal consideration for our determination that the fair value of the IPR&D technology intangible asset and royalty based contingent consideration is a critical audit matter is that the inputs and assumptions utilized by management require significant judgment and result in a high degree of estimation uncertainty.
−Removed: The subjectivity of the estimate increases the level of auditor judgment and effort to evaluate management’s significant assumptions, including (i) future expected revenues and cash flows and (ii) discount rates.
−Removed: Further, changes in these assumptions and judgments could have a significant impact on the recorded fair values.
−Removed: Our audit procedures related to the fair value of the IPR&D technology and royalty based contingent consideration included the following, among others:
+Added: The purchase consideration transferred in this transaction included, in part, contingent consideration related to royalty payments through December 31, 2034, representing a mid-single digit percentage of future revenues associated with the acquired in-process research and development technology intangible asset.
+Added: The royalty based contingent consideration is adjusted to fair value at each reporting period.
+Added: The estimated fair value of the royalty based contingent consideration as of December 31, 2025 was $9.1 million.
+Added: We identified the fair value determinations of the royalty based contingent consideration as a critical audit matter.
+Added: The principal consideration for our determination that the fair value of the royalty based contingent consideration is a critical audit matter is that the inputs and assumptions utilized by management require significant judgment and result in a high degree of estimation uncertainty.
+Added: The subjectivity of the estimate increases the level of auditor judgment and effort to
+Added: evaluate management’s significant assumptions, including (i) future expected revenues and (ii) discount rates.
+Added: Further, changes in these assumptions and judgments could have a significant impact on the recorded fair value.
+Added: Our audit procedures related to the fair value of the royalty based contingent consideration included the following, among others:
• Evaluated the design and operating effectiveness of key controls related to management’s processes over the development of the fair value estimates and related key inputs and assumptions, and over the evaluation of the competency and objectivity of management's third-party valuation specialist.
• Tested the mathematical accuracy of the valuation models utilized and the completeness, accuracy and relevance of underlying data used in the model.
−Removed: • Assessed the reasonableness of management’s estimated revenues and cash flows by obtaining an understanding of management’s processes for developing projected financial information, including inspection of relevant market data and other supporting documentation.
+Added: • Assessed the reasonableness of management’s estimated revenues by obtaining an understanding of management’s processes for developing projected financial information, including inspection of relevant market data and other supporting documentation.
• Utilized valuation specialists to evaluate the reasonableness of the methodology and discount rates used in the valuation.
8 unchanged sentences
Opinion on the Consolidated Financial Statements
−Removed: We have audited the accompanying consolidated balance sheet of OraSure Technologies, Inc.
−Removed: and subsidiaries (the Company) as of December 31, 2023, the related consolidated statements of operations, comprehensive income (loss), stockholders’ equity, and cash flows for each of the years in the two-year period ended December 31, 2023, and the related notes (collectively, the consolidated financial statements).
−Removed: In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023, and the results of its operations and its cash flows for each of the years in the two-year period ended December 31, 2023, in conformity with U.S.
+Added: We have audited the accompanying consolidated statements of operations, comprehensive (loss) income, stockholders’ equity, and cash flows of OraSure Technologies, Inc.
+Added: and subsidiaries (the Company) for the year ended December 31, 2023, and the related notes (collectively, the consolidated financial statements).
+Added: In our opinion, the consolidated financial statements present fairly, in all material respects, the results of operations of the Company and its cash flows for the year ended December 31, 2023, in conformity with U.S.
generally accepted accounting principles.
1 unchanged sentence
These consolidated financial statements are the responsibility of the Company’s management.
−Removed: Our responsibility is to express an opinion on these consolidated financial statements based on our audits.
−Removed: We are a public accounting firm registered with the Public Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S.
+Added: Our responsibility is to express an opinion on these consolidated financial statements based on our audit.
+Added: We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S.
federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
−Removed: We conducted our audits in accordance with the standards of the PCAOB.
+Added: We conducted our audit in accordance with the standards of the PCAOB.
Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.
−Removed: Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks.
+Added: Our audit included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks.
Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements.
−Removed: Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.
−Removed: We believe that our audits provide a reasonable basis for our opinion.
+Added: Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.
+Added: We believe that our audit provides a reasonable basis for our opinion.
We served as the Company’s auditor from 2002 to 2024.
32 unchanged sentences
Operating lease liability 2,164 2,129
+Added: Acquisition-related contingent consideration obligation 18,380 —
Total current liabilities 39,795 33,483
4 unchanged sentences
Other noncurrent liabilities 2,243 494
−Removed: Deferred income taxes — 554
Total noncurrent liabilities 22,546 35,838
28 unchanged sentences
Change in the estimated fair value of acquisition-related contingent consideration 4,570 — ( 99 )
+Added: Gain on sale of assets ( 725 ) — —
120,167 107,640 138,968
1 unchanged sentence
OTHER INCOME 7,383 12,249 23,574
−Removed: (Loss) Income before income taxes ( 16,001 ) 56,258 ( 15,675 )
+Added: (Loss) income before income taxes and equity investment ( 64,586 ) ( 16,001 ) 56,258
INCOME TAX EXPENSE 1,801 1,799 2,603
+Added: (LOSS) INCOME BEFORE EQUITY INVESTMENT ( 66,387 ) ( 17,800 ) 53,655
LOSS ON EQUITY INVESTMENT ( 2,344 ) ( 1,700 ) —
9 unchanged sentences
AND SUBSIDIARIES
−Removed: CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
+Added: CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS) INCOME
(in thousands)
2 unchanged sentences
NET (LOSS) INCOME $ ( 68,731 ) $ ( 19,500 ) $ 53,655
−Removed: OTHER COMPREHENSIVE (LOSS) INCOME
+Added: OTHER COMPREHENSIVE INCOME (LOSS)
Currency translation adjustments 5,956 ( 9,419 ) 3,274
18 unchanged sentences
Stock-based compensation — — 10,729 — — 10,729
−Removed: Net loss — — — — ( 17,133 ) ( 17,133 )
+Added: Net income — — — — 53,655 53,655
Currency translation adjustments — — — 3,274 — 3,274
5 unchanged sentences
Stock-based compensation — — 11,920 — — 11,920
−Removed: Net income — — — — 53,655 53,655
+Added: Net loss — — — — ( 19,500 ) ( 19,500 )
Currency translation adjustments — — — ( 9,419 ) — ( 9,419 )
−Removed: Unrealized gain on marketable securities — — — 220 — 220
Balance at December 31, 2024 74,598 $ — $ 538,129 $ ( 24,360 ) $ ( 103,431 ) $ 410,338
−Removed: Common stock issued upon exercise of options 32 — 214 — — 214
−Removed: Vesting of restricted stock and performance stock units 1,678 — — — — —
+Added: Shares repurchased and retired in satisfaction of minimum tax withholding for vested restricted stock and performance stock units 1,640 — — — — —
Purchase and retirement of common shares ( 564 ) — ( 1,843 ) — — ( 1,843 )
Stock-based compensation — — 10,147 — — 10,147
+Added: Shares repurchased and retired in connection with share repurchase program ( 5,283 ) — ( 15,040 ) — — ( 15,040 )
Net loss — — — — ( 68,731 ) ( 68,731 )
10 unchanged sentences
Net (loss) income $ ( 68,731 ) $ ( 19,500 ) $ 53,655
−Removed: Adjustments to reconcile net (loss) income to net cash provided by (used in) operating activities
+Added: Adjustments to reconcile net (loss) income to net cash (used in) provided by operating activities
Stock-based compensation 10,147 11,920 10,729
3 unchanged sentences
Provision for credit losses ( 65 ) 71 ( 462 )
−Removed: Unrealized foreign currency (gain) loss ( 263 ) 103 ( 161 )
+Added: Unrealized foreign currency loss (gain) 365 ( 263 ) 103
Interest expense on finance leases 8 22 51
1 unchanged sentence
Deferred income taxes 1,853 ( 657 ) 102
−Removed: Loss on sale of fixed assets 563 — 729
+Added: (Gain) loss on sale of fixed assets ( 725 ) 563 —
Change in the estimated fair value of acquisition-related contingent consideration 4,570 — ( 99 )
7 unchanged sentences
Accrued expenses and other liabilities ( 8,663 ) ( 6,443 ) ( 3,384 )
−Removed: Net cash provided by (used in) operating activities 27,374 141,583 ( 47,202 )
+Added: Net cash (used in) provided by operating activities ( 49,023 ) 27,374 141,583
INVESTING ACTIVITIES:
Purchases of short-term investments — ( 53,244 ) ( 74,652 )
+Added: Proceeds from maturities and redemptions of investments — 53,052 102,440
Purchase of equity method investee — ( 30,000 ) —
−Removed: Proceeds from maturities and redemptions of short-term investments 53,052 102,440 47,415
Acquisition of business, net of cash acquired ( 3,613 ) ( 5,037 ) —
2 unchanged sentences
Purchase of property and equipment under government contracts — — ( 4,501 )
−Removed: Proceeds from funding under government contract — 48,669 60,331
+Added: Proceeds from funding under government contracts — — 48,669
Net cash (used in) provided by investing activities ( 6,810 ) ( 39,026 ) 66,154
2 unchanged sentences
Proceeds from exercise of stock options — 214 269
−Removed: Payment of acquisition-related contingent consideration — ( 46 ) ( 208 )
Repurchase of common stock ( 15,040 ) — —
+Added: Payment of acquisition-related contingent consideration — — ( 46 )
+Added: Payment of taxes related to net share settlement of equity awards ( 1,843 ) ( 3,548 ) ( 1,901 )
Net cash used in financing activities ( 16,944 ) ( 4,176 ) ( 3,023 )
EFFECT OF FOREIGN EXCHANGE RATE CHANGES ON CASH 4,292 ( 6,816 ) 1,713
−Removed: NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS ( 22,644 ) 206,427 ( 32,782 )
+Added: NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS ( 68,485 ) ( 22,644 ) 206,427
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD 267,763 290,407 83,980
4 unchanged sentences
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
−Removed: (in thousands, except per share amounts, unless otherwise indicated)
−Removed: OraSure Technologies transforms health through actionable insight by powering the shift that connects people to healthcare wherever they are.
+Added: (all tabular amounts in thousands)
+Added: OraSure Technologies transforms health through actionable insight and decentralizes diagnostics to connect people to healthcare wherever they are.
In February 2023, the Company announced a corporate restructuring to combine the commercial and innovation teams across two segments, being the “Diagnostics” segment and the “Molecular Solutions” segment, into one business unit with sales, marketing, product development, and research teams covering multiple product lines.
2 unchanged sentences
The Company's product portfolio is broadly divided into diagnostics products and sample management solutions.
−Removed: The Company's business consists of the development, manufacture, marketing and sale of simple, easy to use specimen collection devices and diagnostic products designed to detect certain infectious diseases including COVID-19, HIV and Hepatitis C, and Syphilis that are performed on a rapid basis at the point of care.
+Added: The Company's business consists of the development, manufacture, marketing and sale of simple, easy to use specimen collection devices and diagnostic products designed to detect certain infectious diseases including HIV, Hepatitis C, Syphilis and Sickle Cell that are performed on a rapid basis at the point of care.
The Company's business also includes sample management solutions and molecular services that are used by clinical laboratories, direct-to-consumer laboratories, researchers, pharmaceutical companies, and animal health service and product providers.
During 2024, the Company exited the molecular services business.
−Removed: In October 2024, the Company announced the discontinuance of the sales of its risk assessment product line which is expected to be completed in the first half of 2025.
+Added: In October 2024, the Company announced the discontinuance of the sales of its risk assessment product line which was completed in the first half of 2025.
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES:
3 unchanged sentences
("DNAG"), Diversigen, Inc.
−Removed: ("Diversigen"), Novosanis NV ("Novosanis"), and Sherlock Biosciences, Inc.
+Added: ("Diversigen"), Novosanis NV ("Novosanis"), BioMedomics, Inc.
+Added: ("BioMedomics") and Sherlock Biosciences, Inc.
("Sherlock").
+Added: Novosanis was legally dissolved in June 2025.
All intercompany transactions and balances have been eliminated.
References herein to “we”, “us”, “our”, or the “Company” mean OraSure and its consolidated subsidiaries, unless otherwise indicated.
+Added: Change in Accounting Principle
+Added: Effective January 1, 2025, the Company changed its methodology for valuing certain inventories to the average cost method from the first-in, first-out ("FIFO") cost method.
+Added: The change was applicable to all inventories.
+Added: The Company concluded that the average cost basis of accounting is preferable as it results in greater precision in the calculation of acquisition cost of inventory on the balance sheet.
+Added: The effect of this change in accounting principle was immaterial.
+Added: Therefore, retroactive application was not determined to be necessary and a cumulative adjustment of $ 0.1 million was recorded in the statement of operations for the twelve months ended December 31, 2025.
Use of Estimates
7 unchanged sentences
Supplemental Cash Flow Information
−Removed: The Company paid income tax of $ 1.8 million in 2024, and received income tax refunds of $ 4.9 million in 2023 and paid income tax of $ 9.4 million in 2022.
+Added: The Company paid income taxes of $ 1.8 million and $ 1.8 million in 2025 and 2024, respectively, and received income tax refunds of $ 4.9 million in 2023.
The Company had account receivable write-offs of $ 0.5 million, $ 0.5 million, and $ 0.7 million in 2025, 2024, and 2023, respectively.
As of December 31, 2025, 2024 and 2023, the Company had accruals for purchases of property and equipment of $ 0.5 million, $ 0.5 million and $ 0.2 million, respectively.
−Removed: The Company acquired Sherlock in exchange for contingent consideration of $ 22,910 for the year ended December 31, 2024 .
+Added: The Company acquired BioMedomics which included contingent consideration of $ 0.3 million for the year ended December 31, 2025.
+Added: The Company acquired Sherlock which included contingent consideration of $ 22.9 million for the year ended December 31, 2024.
Cash Equivalents & Short-Term Investments
2 unchanged sentences
Securities with maturities ninety days or less are considered cash equivalents.
−Removed: Available-for-sale securities are carried at fair value, based upon quoted market prices, with unrealized gain and losses, if any, reported in stockholders' equity as a component of other comprehensive loss.
+Added: Available-for-sale securities are carried at fair value, based upon quoted market prices, with unrealized gains and losses, if any, reported in stockholders’ equity as a component of accumulated other comprehensive loss.
The Company records an allowance for credit loss for the Company's available-for-sale securities when a decline in investment market value is due to credit-related factors.
When evaluating an investment for impairment, the Company reviews factors such as the severity of the impairment, changes in underlying credit ratings, forecasted recovery, the Company’s intent to sell or the likelihood that it would be required to sell the investment before its anticipated recovery in market value, and the probability that the scheduled cash payments will continue to be made.
−Removed: The Company had no available-for-sale securities as of December 31, 2024 and 2023.
+Added: The Company had no available-for-sale securities as of December 31, 2025 and December 31, 2024.
The Company maintains cash balances in the United States in excess of the federally insured limits.
+Added: The Company periodically evaluates financial institutions and believes the risk of loss to be remote due to this evaluation.
Fair Value of Financial Instruments
7 unchanged sentences
Therefore, the degree of judgment exercised in determining fair value is greatest for assets or liabilities categorized in Level 3.
+Added: December 31, December 31,
Level 2025 2024
Guaranteed investment certificates 1 $ 13,114 $ 66,584
+Added: Trading securities 1 543 724
Contingent consideration:
+Added: Current portion $ 18,380 $ —
+Added: Long-term portion 9,333 22,910
+Added: $ 27,713 $ 22,910
Included in cash and cash equivalents at December 31, 2025 and 2024 was $ 13.1 million and $ 66.6 million, respectively, invested in guaranteed investment certificates.
7 unchanged sentences
The fair value of the plan assets as of December 31, 2025 and 2024 was $ 0.5 million and $ 0.7 million, respectively, and was calculated using the quoted market prices of the assets as of those dates.
−Removed: All investments in the plan are classified as trading
−Removed: securities and measured as Level 1 instruments.
+Added: All investments in the plan are classified as trading securities and measured as Level 1 instruments.
The fair value of plan assets is included in both current assets and other noncurrent assets with the same amounts included in accrued expenses and other noncurrent liabilities in the accompanying consolidated balance sheets .
Contingent Consideration
−Removed: As further discussed in Note 14, Business Combinations, the Company has identified its contingent consideration obligations as Level 3 liabilities due to significant inputs that are required to measure the fair value of these obligations.
−Removed: The contingent consideration is comprised of two different tranches:
−Removed: milestone payments and royalty payments.
+Added: As discussed further in Note 13, Business Combinations, the Company has identified its contingent consideration obligations as Level 3 liabilities due to significant inputs that are required to measure the fair value of these obligations.
+Added: The contingent consideration is comprised of three different tranches:
+Added: milestone payments, royalty payments, and earnout payments.
The significant quantitative unobservable inputs for the milestone payments are the discount rate and probability achievement of a milestone of a regulatory approval.
−Removed: The fair value methodology for royalty payments are based on a discounted cash flow model.
+Added: The fair value methodology for royalty payments is based on a discounted cash flow model.
Significant quantitative unobservable inputs are internally developed future expected cash flows, discount rate and probability achievement of a milestone of a regulatory approval.
−Removed: The royalty payments represent a mid-single digit percentage of the net sales through 2034 associated with the acquired in-process and research developed intangible asset.
−Removed: There were no changes in fair value from date of acquisition to December 31, 2024.
+Added: The royalty payments represent a mid-single digit percentage of the net sales through 2034 associated with the acquired in-process and research and development intangible asset.
+Added: The fair value methodology for earnout payments is based on a Monte Carlo model.
+Added: Significant quantitative unobservable inputs are future expected cash flows, discount rate and volatility rate.
+Added: There was an increase of $ 4.6 million in the fair value of the Company's contingent consideration from date of acquisition to December 31, 2025 for the milestone and royalty payments.
+Added: Balance at December 31, 2024 $ 22,910
+Added: Additions 233
+Added: Change in fair value 4,570
+Added: Balance at December 31, 2025 $ 27,713
Equity Method Investee
−Removed: In January 2024, the Company lead the Series B financing and entered into wide-ranging strategic distribution agreements with KKR Sapphiros L.P.
+Added: In January 2024, the Company led the Series B financing and entered into wide-ranging strategic distribution agreements with KKR Sapphiros L.P.
("Sapphiros"), a privately held consumer diagnostic portfolio company, and certain of its related entities.
−Removed: Through this relationship, the Company expects to be able to offer a more comprehensive range of low-cost diagnostic tests and sample management solutions to the Company's customers globally.
+Added: Through this relationship, the Company expects to be able to offer a more comprehensive range of low-cost diagnostic tests and molecular sample management solutions to the Company's customers globally.
As of December 31, 2025, the Company had funded $ 30.0 million for its interest in Sapphiros.
1 unchanged sentence
In accordance with the equity method, the Company's equity investment is presented net of its share of any gains or losses of the investee.
−Removed: The Company has elected as its accounting policy to recognize its share of any income or loss in Sapphiros on a three-month lag, which coincides with the availability of its financial information.
−Removed: The investment in Sapphiros of $ 28.3 million as of December 31, 2024 is included in the investment in equity method investee line of the Company's balance sheet and is measured as a Level 3 investment.
+Added: The Company has elected as its accounting policy to recognize its share of any income or loss in Sapphiros on a three-month lag.
+Added: The investment in Sapphiros of $ 26.0 million as of December 31, 2025 is included in the investment in equity method investee line of the Company's balance sheet.
The Company has no unconditional obligations or guarantees to, or in support of, its equity method investee and its operations.
−Removed: In conjunction with the preparation of the Company's December 31, 2024 financial statements, the Company considered whether the carrying value of the investment in Sapphiros was impaired and concluded that no such impairment existed.
−Removed: There was no similar investment as of December 31, 2023.
+Added: In conjunction with the preparation of the Company's December 31, 2025 financial statements, the Company evaluated the investment in Sapphiros for impairment and concluded there was no such impairment.
+Added: The Company's investment in Sapphiros was valued at $ 28.3 million as of December 31, 2024.
+Added: Related Party
+Added: The Company loaned Sapphiros $ 0.3 million during the year ended December 31, 2025.
+Added: The loan plus interest is due in December 2026.
+Added: During the year ended December 31, 2025, the Company entered into an agreement with Sapphiros to develop certain products for Sapphiros.
+Added: A total of $ 0.2 million of revenue was recognized from this agreement.
Accounts Receivable
4 unchanged sentences
Allowance for doubtful accounts $ 188 $ 774 $ 1,216
−Removed: Inventories are stated at the lower of cost or net realizable value, with cost determined on a first-in, first-out basis, and include the cost of raw materials, labor and overhead.
+Added: Inventories are stated at the lower of cost or net realizable value, with cost determined on an average cost method, and include the cost of raw materials, labor and overhead.
The majority of the Company's inventories are subject to expiration dating, which can be extended in certain circumstances.
The Company continually evaluates quantities on hand and the carrying value of the Company's inventories to determine the need for net realizable value adjustments for excess and obsolete inventories, based primarily on prior experience with consideration of expected changes in the business and estimated forecasts of product sales.
−Removed: The Company reserves for unidentified scrap or spoilage based on historical write-off rates.
+Added: The Company reserves for inventory expiring within ninety days, with the exception of inventory that will be consumed or will have expiration dates extended.
The Company also considers items identified through specific identification procedures in assessing the adequacy of the Company's reserve.
19 unchanged sentences
Expected future cash flows reflect the Company's assumptions about selling prices, volumes, costs and market conditions over a reasonable period of time.
−Removed: See Notes 5 and 6 for discussion of property, plant and equipment and intangible asset impairments, respectively, recorded for the years ended December 31, 2024 and 2023.
+Added: See Note 5 for discussion of property, plant and equipment impairments, recorded for the year ended December 31, 2024.
+Added: See Note 6 for discussion of definite-lived intangible asset impairments, recorded for the year ended December 31, 2023.
Goodwill represents the excess of the purchase price over the fair value of the net tangible and identifiable intangible assets acquired in a business combination.
3 unchanged sentences
The Company historically performed an annual goodwill impairment assessment as of July 31.
−Removed: During the three months ended December 31, 2023, the Company changed the date of its the annual impairment assessment to November 30, to better align with the Company's annual forecasting process.
−Removed: On November 30, 2024, the Company performed a quantitative goodwill impairment test which concluded that the carrying value of the Company's goodwill was below its fair value indicating there was no impairment.
+Added: During the three months ended December 31, 2023, the Company changed the date of the annual impairment assessment to November 30, to better align with the Company's annual forecasting process.
+Added: On November 30, 2025, the Company performed a quantitative goodwill impairment test which concluded that the carrying value of the Company's goodwill for both the diagnostic and collection devices reporting units was below its fair value indicating there was no impairment.
+Added: As of November 30, 2025, the diagnostic reporting unit fair value exceeded its carrying value by 13 %.
+Added: As of December 31, 2025, the diagnostic reporting unit had $ 8.2 million of goodwill.
+Added: The diagnostic reporting unit goodwill impairment analysis used both an income and market approach.
+Added: These two approaches were weighted and the income approach was weighed more than the market approach.
+Added: Key assumptions included revenues increasing each year as products are launched and a weighted-average cost of capital based on guideline companies.
+Added: The revenue and cashflows assumes products are passed by regulatory bodies on a set timeline and market competition of future products is low.
+Added: The revenues assume market growth will accelerate each year.
+Added: If there are delays to attaining regulatory approval or successfully launching products, this could have a negative outcome on the goodwill impairment analysis.
+Added: In addition, if the Company's weighted-average cost of capital is not aligned with guideline companies, this could negatively affect the goodwill impairment outcome.
+Added: The below table illustrates the discount rate and exit multiple sensitivity to the fair value of the diagnostic reporting unit goodwill when performing the goodwill impairment analysis as of November 30, 2025.
+Added: In the annual goodwill impairment analysis as of November 30, 2025, the diagnostic reporting unit utilized a 14% discount rate with an exit multiple of one.
+Added: Exit Multiple
+Added: Discount Rate 0.80 0.90 1.00 1.10 1.20
+Added: 13% $ 208,132 $ 217,464 $ 226,796 $ 236,128 $ 245,460
+Added: 14% 205,252 214,254 223,256 232,258 241,259
+Added: 15% 202,501 211,188 219,875 228,562 237,249
+Added: 16% 199,868 208,254 216,640 225,025 233,411
+Added: 17% 197,339 205,436 213,533 221,630 229,726
A more frequent evaluation is performed if an event occurs or circumstances change between annual tests that could more likely than not reduce the fair value of a reporting unit below its carrying amount.
1 unchanged sentence
Revenue from product sales is recognized upon transfer of control of a product to a customer based on an amount that reflects the consideration the Company is entitled to, net of allowances for any discounts or rebates.
−Removed: The Company generally does not grant product return rights to its customers, except for warranty returns and return rights on sales of the Company's OraQuick ® In-Home HIV test to retail trade customers, and InteliSwab ® products to retail trade and certain other customers.
+Added: The Company generally does not grant product return rights to its customers, except for warranty returns and return rights on sales of the Company's OraQuick ® HIV Self-Test to retail trade customers, and InteliSwab ® products to retail trade and certain other customers.
Historically, returns arising from warranty issues have been infrequent and immaterial.
4 unchanged sentences
The Company recognizes revenues when the Company satisfies its performance obligations for services rendered.
+Added: Service revenues are associated with the Diversigen business, which was discontinued in 2024.
+Added: There were zero service revenues for the year ended December 31, 2025.
Arrangements with multiple performance obligations .
3 unchanged sentences
The consideration allocated to each distinct performance obligation is recognized as revenue when control is transferred for the related goods or services or when the performance obligation has been satisfied.
+Added: Arrangements with multiple performance obligations are associated with the Diversigen business, which was discontinued in 2024.
Other revenues .
1 unchanged sentence
Royalties from licensees are based on third-party sales of licensed products and are recorded when the related third-party product sale occurs.
−Removed: Research and development grant revenue is recognized pursuant to International Accounting Standard 20, Accounting for Government Grants and Disclosure of Government Assistance ("IAS 20") .
+Added: The Company accounts for government grants by analogy to International Accounting Standard 20, Accounting for Government Grants and Disclosure of Government Assistance ("IAS 20"), as U.S.
+Added: GAAP does not provide specific guidance.
+Added: Grants are recognized when there is reasonable assurance that conditions will be met and the grant will be received, and are recognized in earnings over the periods in which the related costs are incurred.
The expenses are recorded in research and development expense and the reimbursements are recorded in other revenue.
Funding of research and development efforts and charitable support reimbursements are recorded as the activities are performed in accordance with the respective agreements.
−Removed: Deferred revenue.
−Removed: The Company records deferred revenue when funds are received prior to the recognition of the associated revenue.
−Removed: Deferred revenue as of December 31, 2024 and 2023 included customer prepayments of $ 3.0 million and $ 1.2 million, respectively.
−Removed: Deferred revenue as of December 31, 2023 also included $ 0.4 million associated with a long-term contract that has variable pricing based on volume.
−Removed: The average price over the life of the contract was determined and revenue was recognized at that average price.
−Removed: The $ 0.4 million associated with the long-term contract at December 31, 2023 met the criteria to be recognized as revenue during the year ended December 31, 2024, and as such there was no equivalent balance remaining in deferred revenue at December 31, 2024.
−Removed: Revenue recognized during the years ended December 31, 2024 and 2023 was $ 3.7 million and $ 2.6 million, respectively, which was included in the beginning period deferred revenue.
−Removed: 2024 2023 2022
−Removed: Deferred revenue $ 2,961 $ 1,559 $ 2,273
Financing and payment .
7 unchanged sentences
If the amortization period exceeds one year, the Company defers the cost of the commission and expenses it over the life of the related sales contract.
−Removed: Revenues by product .
+Added: Revenues by Product Line .
The following table represents total net revenues by product line:
4 unchanged sentences
38,356 51,046 54,274
−Removed: 45,172 257,779 243,325
HCV 13,759 14,024 12,871
+Added: Other product and services revenues (2)
+Added: 4,648 3,506 2,265
Risk Assessment Testing (3)
1,866 8,354 9,736
−Removed: Other product and services revenues (4)
624 45,172 257,779
5 unchanged sentences
(1) Includes Genomics, Microbiome and Colli-Pee ® product revenues.
−Removed: (2) Includes COVID-19 Diagnostics and COVID-19 Molecular Products revenues.
−Removed: (3) Includes substance abuse testing product revenues.
(2) Includes Syphilis revenues.
+Added: (3) Includes substance abuse testing product revenues.
+Added: (4) Includes COVID-19 Diagnostics and COVID-19 Sample Management Solutions revenues.
(5) Includes funded research and development contracts, royalty income and grant revenues.
11 unchanged sentences
For the Years Ended December 31,
−Removed: Revenue Concentration
−Removed: Non-commercial customer (1)
+Added: Net Revenues 2025 2024
+Added: Non-commercial customer N/A 24 %
Accounts Receivable 2025 2024
−Removed: Commercial customer 10 % N/A
−Removed: Non-commercial customer (1)
−Removed: (1) Same non-commercial customer.
+Added: Commercial customer 15 % 10 %
Vendor Concentrations.
3 unchanged sentences
The Company's inability to have a timely supply of any of these components and products could have a material adverse effect on the Company's business, as well as the Company's financial condition and results of operations.
+Added: Deferred Revenue.
+Added: The Company records deferred revenue when funds are received prior to the recognition of the associated revenue.
+Added: Deferred revenue as of December 31, 2025, 2024, and 2023 was comprised of customer prepayments of $ 1.2 million, $ 3.0 million, and $ 1.2 million, respectively.
+Added: Deferred revenue as of December 31, 2025 was also comprised of $ 0.4 million of unearned grant income.
+Added: Deferred revenue as of December 31, 2023 also included $ 0.4 million associated with a long-term contract that has variable pricing based on volume.
+Added: The average price over the life of the contract was determined and revenue was recognized at that average price.
+Added: The $ 0.4 million associated with the long-term contract at December 31, 2023 met the criteria to be recognized as revenue during the year ended December 31, 2024, and as such there was no equivalent balance remaining in deferred revenue at December 31, 2025 or 2024.
+Added: 2025 2024 2023
+Added: Deferred Revenue $ 1,518 $ 2,961 $ 1,559
+Added: The following table represents deferred revenue recognized:
+Added: For the Years Ended December 31,
+Added: Deferred Revenue Recognized 2025 2024
+Added: Accrued at beginning of year $ 2,484 $ 3,680
Research and Development
3 unchanged sentences
Advertising costs are charged to expense as incurred.
−Removed: During 2024, 2023, and 2022, the Company incurred $ 0.5 million, $ 1.6 million, and $ 4.8 million, respectively, in advertising expenses.
+Added: During the years ended December 31, 2025, 2024, and 2023, the Company incurred $ 0.6 million, $ 0.5 million, and $ 1.6 million, respectively, in advertising expenses.
Stock-Based Compensation
11 unchanged sentences
The realization of the net deferred tax assets is dependent on several factors, including the generation of sufficient taxable income prior to the expiration of the Company's net operating loss carryforwards.
+Added: Uncertain Tax Positions
+Added: Assets and liabilities are established for uncertain tax positions taken or positions expected to be taken in income tax returns when such positions fail to meet the "more likely than not" threshold based on the technical merits of the positions.
+Added: The Company assesses whether previously unrecognized tax benefits may be recognized when tax positions are (1) more likely than not of being sustained based on their technical merits, (2) effectively settled through examination, negotiation or litigation, or (3) settled through actual expiration of the relevant tax statutes.
+Added: The assessment of an uncertain tax position requires significant judgment.
Foreign Currency Translation
7 unchanged sentences
Diluted earnings (loss) per share is computed in a manner similar to basic earnings (loss) per share except that the weighted-average number of shares outstanding is increased to include incremental shares from the assumed vesting or exercise of dilutive securities, such as common stock options, unvested restricted stock or performance stock units, unless the impact is anti-dilutive.
−Removed: The number of incremental shares is calculated by assuming that outstanding stock options were exercised and unvested restricted shares and performance stock units were vested, and the proceeds from such exercises or vesting were used to acquire shares of common stock at the average market price
−Removed: during the reporting period.
+Added: The number of incremental shares is calculated by assuming that outstanding stock options were exercised and unvested restricted shares and performance stock units were vested, and the proceeds from such exercises or vesting were used to acquire shares of common stock at the average market price during the reporting period.
Basic and dilutive computations of net loss per share are the same in periods in which a net loss exists as the dilutive effects of excluded items would be anti-dilutive.
1 unchanged sentence
2025 2024 2023
−Removed: Net income (loss) $ ( 19,500 ) $ 53,655 $ ( 17,133 )
+Added: Net (loss) income $ ( 68,731 ) $ ( 19,500 ) $ 53,655
Weighted average shares of common stock outstanding:
2 unchanged sentences
Diluted 73,485 74,434 74,389
−Removed: Earnings per share:
+Added: Loss (earnings) per share:
Basic $ ( 0.94 ) $ ( 0.26 ) $ 0.73
Diluted $ ( 0.94 ) $ ( 0.26 ) $ 0.72
−Removed: For the year ended December 31, 2024, outstanding common stock options, unvested restricted stock, and unvested performance stock units representing 896 shares were excluded from the computation of diluted loss per share.
+Added: For the years ended December 31, 2025 and 2024, outstanding common stock options, unvested restricted stock, and unvested performance stock units representing 572 and 896 shares, respectively, were excluded from the computation of diluted loss per share.
For the year ended December 31, 2023, outstanding common stock options, unvested restricted stock, and unvested performance stock units representing 1,778 shares were excluded from the computation of diluted earnings per share as their inclusion would have been antidilutive.
−Removed: For the year ended December 31, 2022, outstanding common stock options, unvested restricted stock, and unvested performance stock units representing 436 shares were excluded from the computation of diluted loss per share.
Accumulated Other Comprehensive Loss
3 unchanged sentences
dollars, which is the reporting currency of the Company.
−Removed: Changes in accumulated other comprehensive loss by component is listed below:
+Added: Change in accumulated other comprehensive loss by component is listed below:
Foreign Currency Total
Balance at December 31, 2024 $ ( 24,360 ) $ ( 24,360 )
−Removed: Other comprehensive loss ( 9,419 ) ( 9,419 )
+Added: Other comprehensive gain 5,956 5,956
Balance at December 31, 2025 $ ( 18,404 ) $ ( 18,404 )
Recent Accounting Pronouncements
+Added: In December 2023, the FASB issued ASU No.
+Added: 2023-09, Income Taxes (Topic 740), Improvements to Income Tax Disclosures .
+Added: The purpose of the update was to address investor requests for more transparency about income tax information through improvements to income tax disclosures primarily related to the rate reconciliation and incomes taxes paid information.
+Added: The amendments in this ASU are effective for annual periods beginning after December 15, 2024.
+Added: The amendments may be applied prospectively or retrospectively, and early adoption is permitted.
+Added: Management has implemented on a prospective basis for the year ended December 31, 2025.
In November 2024, the Financial Accounting Standards Board ("FASB") issued Accounting Standard Update ("ASU") No.
5 unchanged sentences
In March 2024, the FASB issued ASU No.
−Removed: 2024-01, Compensation—Stock Compensation (Topic 718), Scope Application of Profits Interest and Similar Awards .
+Added: 2024-01, Compensation—Stock Compensation (Topic 718), Measurement of Credit Losses for Accounts Receivable and Contract Assets .
The purpose of this update was to provide illustrative examples to demonstrate how an entity should apply guidance to determine whether profits interests and similar awards should be accounted for in accordance with Topic 718.
−Removed: For public business entities, the amendments in this ASU are effective for fiscal years
−Removed: beginning after December 15, 2024, and interim periods within those fiscal periods.
+Added: For public business entities, the amendments in this ASU are effective for fiscal years beginning after December 15, 2024, and interim periods within those fiscal periods.
The amendments may be applied prospectively or retrospectively, and early adoption is permitted.
+Added: Management does not expect an impact on the Company's consolidated financial statements.
+Added: In July 2025, the FASB issued ASU No.
+Added: 2025-05, Financial Instruments—Credit Losses (Topic 326), Scope Application of Profits Interest and Similar Awards .
+Added: The purpose of this update was to address challenges encountered when applying the guidance in Topic 326, Financial Instruments—Credit Losses, to current accounts receivable and current contract assets arising from transactions accounted for under Topic 606, Revenue from Contracts with Customers illustrative examples to demonstrate how an entity should apply guidance to determine whether profits interests and similar awards should be accounted for in accordance with Topic 718.
+Added: For all business entities, the amendments in this ASU are effective for fiscal years beginning after December 15, 2025, and interim periods within those fiscal periods.
+Added: The amendments are applied prospectively, and early adoption is permitted.
+Added: Management does not expect an impact on the Company's consolidated financial statements.
+Added: In September 2025, the FASB issued ASU No.
+Added: 2025-06, Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40), Targeted Improvements to the Accounting for Internal-Use Software .
+Added: The purpose of this update was to modernize the accounting for software costs.
+Added: For all business entities, the amendments in this ASU are effective for fiscal years beginning after December 15, 2027, and interim periods within those fiscal periods.
+Added: The amendments can be applied prospectively, a modified transition or retrospectively.
+Added: Early adoption is permitted as of the beginning of an annual reporting period.
+Added: Management does not expect an impact on the Company's consolidated financial statements.
+Added: In December 2025, the FASB issued ASU No.
+Added: 2025-10, Government Grants (Topic 832), Accounting for Government Grants Received by Business Entities .
+Added: The purpose of this update was to improve US GAAP by establishing authoritative guidance on the accounting for government grants received by business entities.
+Added: For public business entities, the amendments in this ASU are effective for annual reporting periods beginning after December 15, 2028, and interim reporting periods within those annual reporting periods.
+Added: Early adoption is permitted in both interim and annual reporting periods in which financial statements have not yet been issued or made available for issuance.
+Added: The amendments can be applied under a modified prospective approach, a modified retrospective approach, or a retrospective approach.
Management is evaluating the impact on the Company's consolidated financial statements.
−Removed: In November 2023, the FASB issued ASU No.
−Removed: 2023-07, Segment Reporting (Topic 280), Improvements to Reportable Segment Disclosures .
−Removed: The purpose of the update was to improve financial reporting by requiring disclosures of incremental segment information on an annual and interim basis for all public entities to enable investors to develop more decision-useful financial analyses.
−Removed: The amendments in this ASU are effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted and require retrospective application to all periods presented in the consolidated financial statements.
−Removed: The Company has adopted the amendments for the year ended December 31, 2024.
In December 2025, the FASB issued ASU No.
−Removed: 2023-09, Income Taxes (Topic 740), Improvements to Income Tax Disclosures.
−Removed: The purpose of the update was to address investor requests for more transparency about income tax information through improvements to income tax disclosures primarily related to the rate reconciliation and incomes taxes paid information.
−Removed: The amendments in this ASU are effective for annual periods beginning after December 15, 2024.
−Removed: The amendments may be applied prospectively or retrospectively, and early adoption is permitted.
+Added: 2025-11, Interim Reporting (Topic 270), Narrow-Scope Improvements .
+Added: The purpose of this update was to improve the navigability of the required interim disclosures and clarifying when that guidance is applicable.
+Added: The update also provides additional guidance on what disclosures should be provided in interim periods and adds a principal that requires entities to disclose events since the end of the last annual reporting period that have a material impact on the entity.
+Added: For public business entities, the amendments in this ASU are effective for interim
+Added: reporting periods within annual reporting periods beginning after December 15, 2027.
+Added: Early adoption is permitted.
+Added: The amendments in this update can be applied either prospectively or retrospectively to any or all prior periods presented in the financial statements.
Management is evaluating the impact on the Company's consolidated financial statements.
−Removed: Immaterial Correction of Errors
−Removed: In the first quarter of 2023, the Company identified an immaterial error that was corrected in its consolidated financial statements.
−Removed: Inventories, accounts payable and cost of products and services were reduced by $ 0.5 million, $ 1.3 million and $ 0.8 million, respectively, as of and for the year ended December 31, 2022 to correct for the accounting of a vendor rebate earned in 2022.
−Removed: Furthermore, stockholder's equity at December 31, 2022 increased $ 0.8 million to reflect the reduction in cost of products and services sold.
−Removed: The tax impact of the vendor rebate was negligible.
−Removed: This correction was deemed to be immaterial to the consolidated financial statements as of and for the year ended December 31, 2022.
−Removed: The respective operating activities on the consolidated statement of cash flows for the year ended December 31, 2022 have also been adjusted.
GOVERNMENT CAPITAL CONTRACTS:
7 unchanged sentences
Amounts earned for the Company's guaranteed profit which covered project management costs were recognized straight-line in other income over the term of the government contract.
−Removed: The Company recognized no such income during the year ended December 31, 2024.
−Removed: The Company recognized $ 2.8 million and $ 2.2 million of such income during the years ended December 31, 2023 and 2022, respectively .
+Added: The Company recognized no such income during the years ended December 31, 2025 and 2024.
+Added: The Company recognized $ 2.8 million of such income during the year ended December 31, 2023.
Additionally, in connection with the completion of the contract, the Company recognized $ 12.8 million in excess of the guaranteed profit in other income in the Company's consolidated statement of operations during the year ended December 31, 2023, which reflects the difference in overall spend compared to the firm fixed price contract amount of $ 109.0 million.
1 unchanged sentence
These expenses are reflected in research and development expenses as incurred with the corresponding amount presented in other income.
−Removed: recognized no such costs during the year ended December 31, 2024.
−Removed: The Company recognized $ 2.0 million and $ 1.4 million of such costs during the years ended December 31, 2023 and 2022, respectively.
+Added: The Company recognized no such costs during the years ended December 31, 2025 and 2024.
+Added: The Company recognized $ 2.0 million of such costs during the year ended December 31, 2023.
The activity corresponding to the government contracts included in the Company's consolidated statements of cash flows is as follows:
3 unchanged sentences
Total property, plant and equipment, net $ —
+Added: December 31, December 31,
Raw materials $ 14,831 $ 17,002
Work in process 56 420
+Added: Semi-finished goods 1,965 2,890
Finished goods 14,208 13,885
$ 31,060 $ 34,197
−Removed: During the years ended December 31, 2024, 2023, and 2022, the Company recorded adjustments to inventory which had a cost of $ 2.6 million, $ 8.9 million, and $ 15.6 million, respectively.
−Removed: Adjustments for the year ended December 31, 2024 were primarily driven by the write down of inventory based on an estimated amount of inventory that may not be sold as the Company exits the Risk Assessment Testing business and normal operating scrap.
+Added: During the years ended December 31, 2025, 2024, and 2023, the Company recorded writedowns to inventory which had a cost of $ 2.9 million, $ 2.6 million, and $ 8.9 million, respectively.
+Added: Adjustments for the year ended December 31, 2025 were primarily driven by the write down of COVID-19 inventory and normal operating scrap.
+Added: Adjustments for the year ended December 31, 2024 were primarily driven by the write down of inventory associated with the Company's exit of the Risk Assessment Testing business and normal operating scrap.
Adjustments for the year ended December 31, 2023 were primarily related to reduction in COVID-19 demand and the need to reserve for excess inventory levels.
−Removed: Additionally, a significant portion of the Company's 2022 adjustments were related to production and tech-transfer issues associated with the Company's COVID-19 rapid test.
−Removed: PROPERTY, PLANT AND EQUIPMENT:
+Added: PROPERTY, PLANT, AND EQUIPMENT, NET:
+Added: December 31, December 31,
Land $ 1,118 $ 1,118
8 unchanged sentences
During the first quarter of 2024, the Company initiated a strategic plan to transition away from the microbiome molecular sequencing services business and to cease operations at its Belgium location.
−Removed: As a result of these decisions, the Company determined that the carrying values of all of Diversigen's and Novosanis's property, plant, and equipment were not recoverable and recorded an aggregate pre-tax asset impairment charge of $ 1.8 million during the year ended December 31, 2024.
+Added: As a result of these decisions, the Company determined that the carrying values of all of associated property, plant, and equipment were not recoverable and recorded an aggregate pre-tax asset impairment charge of $ 1.8 million during the year ended December 31, 2024.
All of these assets were disposed of as of December 31, 2024.
1 unchanged sentence
As a result of this decision, the Company determined that the carrying value of the equipment was not recoverable and recorded an aggregate pre-tax impairment charge of $ 1.1 million during the year ended December 31, 2024.
−Removed: During the year ended December 31, 2023 the Company determined several manufacturing lines would not utilized due to changes in forecasted demand for the products the lines are intended to produce.
+Added: During the year ended December 31, 2023 the Company determined several manufacturing lines would not be utilized due to changes in forecasted demand for the products the lines are intended to produce.
Additionally, the Company elected not to proceed with certain leasehold improvements to its research and development laboratories.
As a result of these decisions, the Company determined that the carrying values of the equipment and leasehold improvements were not recoverable and recorded aggregate pre-tax asset impairment charges of $ 2.3 million for the year ended December 31, 2023.
−Removed: During the year ended December 31, 2022, the Company determined several manufacturing lines and associated supporting assets would not be utilized due to changes in forecasted demand for the products the lines are intended to produce.
−Removed: As a result of this decision, the Company determined that the carrying values of the equipment and supporting assets were not recoverable and recorded aggregate pre-tax asset impairment charges of $ 13.5 million for the year ended December 31, 2022.
−Removed: Due to the extremely specialized nature of the equipment and various market data points, the estimated fair value was zero.
−Removed: These charges are reported within loss on impairments in the consolidated statement of operations.
During the year ended December 31, 2023, the Company shortened the useful lives of machinery and equipment utilized for InteliSwab® production in Thailand.
5 unchanged sentences
Changes in goodwill are as follows:
−Removed: Collection Device Reporting Unit 2024 2023
−Removed: Balance as of January 1 $ 35,696 $ 35,104
+Added: Reporting Unit
+Added: Diagnostics Collection Devices Total
+Added: Balance at January 1, 2024 $ — $ 35,696 $ 35,696
+Added: Acquisition 6,388 — 6,388
Change related to foreign currency translation — ( 1,754 ) ( 1,754 )
−Removed: Balance as of December 31 33,942 35,696
−Removed: Diagnostics Reporting Unit
−Removed: Balance as of January 1 — —
+Added: Balance at December 31, 2024 6,388 33,942 40,330
Acquisition 1,775 — 1,775
−Removed: Balance as of December 31 6,388 —
−Removed: $ 40,330 $ 35,696
+Added: Change related to foreign currency translation — 1,258 1,258
+Added: Balance at December 31, 2025 $ 8,163 $ 35,200 $ 43,363
On November 30, 2025, the Company performed its quantitative annual goodwill impairment test.
1 unchanged sentence
The test concluded that the carrying value of the Company's reporting units was below fair value indicating there was no impairment of goodwill.
−Removed: During 2022, the Company determined that a triggering event occurred in relation to the depressed market price of the Company's common stock and corresponding decline in the Company's market capitalization.
−Removed: As a result, the Company performed an interim quantitative goodwill impairment test and concluded that the carrying value of the Company's Diagnostics reporting unit exceeded its estimated fair value and the goodwill balance for that segment was fully impaired.
−Removed: The Company recognized a pre-tax impairment charge of $ 3.6 million during the year ended December 31, 2022, which is reported in loss on impairments in the Company's consolidated statement of operations.
Intangible assets consist of the following:
23 unchanged sentences
32,848 ( 32,413 ) 435
+Added: Indefinite Life Intangible Assets
+Added: IPR&D technology (Note 13) N/A 17,000 — 17,000
+Added: $ 49,848 $ ( 32,413 ) $ 17,435
During 2023, the Company identified a triggering event to test for the recoverability of intangible assets given the decline in the Company's market capitalization leading up to and as of its annual goodwill impairment testing date.
−Removed: The Company performed an undiscounted cash flow analysis and determined the carrying value of the developed technology, trade names, and customer relationships intangible assets could not be recovered through the sum of the undiscounted future cash flows.
+Added: The Company performed an undiscounted cash flow analysis and determined the carrying value of the developed technology, trade names, and customer relationships intangible assets could not be recovered through the sum of the undiscounted future
The Company used an income approach to determine the fair value of the developed technology and customer relationships intangible assets and the relief from royalty method for the trade names.
7 unchanged sentences
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES:
+Added: December 31, December 31,
Payroll and related benefits $ 5,255 $ 11,147
7 unchanged sentences
This was accounted for pursuant to ASC 420, Exit or Disposal Cost Obligations .
−Removed: The charges for termination benefits included in the Company's consolidated statements of operations are as follows (in thousands):
+Added: The charges for termination benefits included in the Company's consolidated statements of operations are as follows:
For the Year Ended December 31,
4 unchanged sentences
As of December 31, 2024 the Company had fully paid the $ 3.3 million related to the reduction in workforce.
−Removed: No additional expense associated with the 2023 reduction in workforce was incurred during the year ended December 31, 2024.
This reduction in workforce was completed by June 30, 2024.
1 unchanged sentence
During the first quarter of 2024, the Company executed a reduction in workforce largely affecting its COVID-19 manufacturing workforce.
−Removed: This was accounted for pursuant to ASC 420, Exit or Disposal Cost Obligations .
−Removed: The charges for termination benefits included in the Company's consolidated statement of operations are as follows (in thousands):
+Added: The charges for termination benefits included in the Company's consolidated statement of operations are as follows:
For the Year Ended December 31,
7 unchanged sentences
During the second quarter of 2024, the Company executed an additional reduction in workforce as the Company notified employees of its intention to consolidate its Novosanis site in Belgium into other locations by the end of December 31, 2024, discontinue the Diversigen molecular services line of business by the end of June 30, 2024, and consolidate facilities by bringing third-party manufacturing activities into its Pennsylvania facilities by the end of the third quarter of 2025.
−Removed: This was accounted for pursuant to ASC 420, Exit or Disposal Cost Obligations .
−Removed: The charges for termination benefits included in the Company's consolidated statements of operations are as follows (in thousands):
+Added: The charges for termination benefits included in the Company's consolidated statements of operations are as follows:
For the Year Ended December 31,
4 unchanged sentences
As of December 31, 2025 the Company had $ 0.1 million accrued and had paid $ 1.5 million related to the reduction in workforce.
−Removed: The Company expects this reduction in workforce to be completed by September 2025.
+Added: No additional expenses were incurred during the year ended December 31, 2025.
+Added: The Company expects this reduction in workforce to be completed by March 2026.
Q3 2024 Reduction in Workforce
1 unchanged sentence
Additional employees were notified in the fourth quarter of 2024.
−Removed: This was accounted for pursuant to ASC 420, Exit or Disposal Cost Obligations .
−Removed: The charges for termination benefits included in the Company's consolidated statements of operations are as follows (in thousands):
+Added: The charges for termination benefits included in the Company's consolidated statements of operations are as follows:
For the Year Ended December 31,
4 unchanged sentences
As of December 31, 2025 the Company had $ 0.1 million accrued and had paid $ 1.1 million related to the reduction in workforce.
−Removed: The Company expects this reduction in workforce to be completed by January 2026.
+Added: No additional expense was incurred during the year ended December 31, 2025.
+Added: The Company expects this reduction in workforce to be completed by September 2026.
The Company determines whether an arrangement is a lease at inception.
1 unchanged sentence
As of December 31, 2025, the Company is the lessee in all lease agreements.
−Removed: The Company's leases have remaining lease terms of one to ten years , some of which include options to extend the leases based on agreed upon terms, and some of which include options to terminate the leases within one year .
+Added: The Company's leases have remaining lease terms of one to eight years , some of which include options to extend the leases based on agreed upon terms, and some of which include options to terminate the leases within one year .
+Added: The Company also subleased two of its leased corporate offices.
+Added: One of the subleases was terminated during the third quarter of 2025 as the Company exited the head lease agreement.
+Added: The Company's remaining sublease has a remaining term of approximately one year .
The Company presents the operating right-of-use asset amortization and the change in operating lease liabilities on the other non-cash amortization line item of the consolidated statements of cash flows.
11 unchanged sentences
Variable and short-term lease cost 37 549 381
+Added: Sublease income ( 161 ) ( 151 ) ( 155 )
Finance lease cost:
25 unchanged sentences
2028 34 2,157
−Removed: 2028 25 2,081
Thereafter — 3,778
9 unchanged sentences
$ ( 64,586 ) $ ( 16,001 ) $ 56,258
+Added: In July of 2025, the One Big Beautiful Bill Act of 2025 (the “OBBBA”) was enacted in the U.S.
+Added: The OBBBA includes several significant tax provisions, including the reinstatement of full expensing of domestic research and development costs among other domestic and international changes.
+Added: The OBBBA is not expected to have a significant impact on the Company’s tax expense or cash paid for taxes.
+Added: Our results for the year ended December 31, 2025 include the impact of the OBBBA on our consolidated financial statements.
The components of income tax expense (benefit) are as follows:
12 unchanged sentences
Total income tax expense $ 1,801 $ 1,799 $ 2,603
−Removed: For the years ended December 31, 2024, 2023, and 2022 the Company recorded net foreign income tax expense of $ 1.4 million, $ 0.7 million, and $ 0.5 million, respectively.
−Removed: The Company's 2022 foreign income tax expense included $ 1.7 million of Canadian withholding taxes paid on the repatriation of Canadian earnings offset by a foreign income tax benefit of $ 1.2 million associated with the Company's Canadian subsidiary.
+Added: For the year ended December 31, 2025, the Company recorded net foreign tax benefit of $ 0.3 million.
+Added: For the years ended December 31, 2024, and 2023 the Company recorded net foreign income tax expense of $ 1.4 million, and $ 0.7 million, respectively.
For the years ended December 31, 2025, 2024, and 2023 the Company recorded U.S.
−Removed: federal tax expense of $ 0.2 million and state tax expense of $ 0.1 million, $ 1.9 million, and $ 1.0 million respectively.
+Added: federal tax expense of
+Added: $ 0.2 million, $ 0.2 million, and $ 0.0 million, respectively and state tax expense of $ 1.9 million, $ 0.1 million, and $ 1.9 million respectively.
+Added: Total cash paid for income taxes was as follows:
+Added: For the Year Ended December 31, 2025
+Added: United Kingdom ( 672 )
+Added: Total cash paid for income taxes (net of refunds) (1)
+Added: (1) Total cash paid for income taxes during the year ended December 31, 2024 was $ 1.8 million.
+Added: The Company received income tax refunds of $ 4.9 million for year ended December 31, 2023 (prior to adoption of ASU 2023-09).
The reconciliation of the statutory United States federal income tax rate to the Company's effective tax rate is as follows:
8 unchanged sentences
and foreign tax credits 1.3 1.2 1.3
+Added: Uncertain tax positions ( 2.9 ) — —
Nondeductible expenses and other 1.2 ( 2.4 ) 0.9
Nondeductible transaction costs ( 0.2 ) ( 2.1 ) —
+Added: NOL adjustment, domestic ( 2.2 ) — —
NOL adjustment, foreign 25.5 ( 31.4 ) —
+Added: Change in the estimated fair value of acquisition-related contingent consideration ( 1.4 ) — —
+Added: Acquisition adjustments ( 8.7 ) — —
Non-controlling interests ( 0.7 ) 2.2 —
2 unchanged sentences
Effective tax rate ( 2.7 ) % ( 11.2 ) % 4.6 %
+Added: The reconciliation of the statutory United States federal income tax rate to the Company's effective tax rate is as follows:
+Added: For the Year Ended December 31, 2025
+Added: Dollars Percentage
+Added: Statutory U.S.
+Added: federal income tax rate $ ( 14,055 ) 21.0 %
+Added: State and local income taxes, net of federal income tax effect (1)
+Added: 325 ( 0.5 ) %
+Added: Foreign tax effects
+Added: United Kingdom
+Added: Change in NOL limitation ( 17,062 ) 25.5 %
+Added: Intangible acquisition adjustment 4,524 ( 6.7 ) %
+Added: Change in valuation allowances 12,728 ( 19.0 ) %
+Added: Other ( 195 ) 0.3 %
+Added: Other foreign jurisdictions 114 ( 0.2 ) %
+Added: Effect of changes in tax laws/rates enacted in the current period — — %
+Added: Effect of cross-border tax laws
+Added: Global intangible low-taxed income 523 ( 0.8 ) %
+Added: Research and development tax credits ( 536 ) 0.8 %
+Added: Changes in valuation allowances 8,700 ( 13.0 ) %
+Added: Nontaxable or nondeductible items
+Added: Share based payment awards 773 ( 1.1 ) %
+Added: Nondeductible officer's compensation 714 ( 1.1 ) %
+Added: Change in the estimated fair value of acquisition-related contingent consideration 960 ( 1.4 ) %
+Added: Other 192 ( 0.3 ) %
+Added: Changes in unrecognized tax benefits 1,728 ( 2.6 ) %
+Added: Acquisition adjustments 1,285 ( 1.9 ) %
+Added: NOL adjustment 1,441 ( 2.2 ) %
+Added: Other adjustments ( 358 ) 0.5 %
+Added: Effective tax rate $ 1,801 ( 2.7 ) %
+Added: (1) The tax effect in this category was primarily driven by state taxes in Pennsylvania (greater than 50%).
Deferred income taxes reflect the tax effects of temporary differences between the basis of assets and liabilities recognized for financial reporting purposes and tax purposes, and net operating loss and tax credit carryforwards.
Significant components of the Company's deferred tax assets (liabilities) are as follows:
−Removed: Deferred tax assets (liabilities):
+Added: Deferred tax assets:
Net operating loss carryforwards $ 54,859 $ 55,583
2 unchanged sentences
Accruals and reserves currently not deductible 1,805 2,754
−Removed: Acquired intangible assets ( 3,981 ) ( 164 )
Depreciation and amortization 114 —
−Removed: Right-of-use assets ( 2,266 ) ( 3,010 )
Lease liabilities 2,254 2,497
3 unchanged sentences
Valuation allowance ( 77,006 ) ( 75,191 )
−Removed: Net deferred tax asset (liability) $ 156 $ ( 554 )
+Added: Total deferred tax assets $ 4,895 $ 8,420
+Added: Deferred tax liabilities:
+Added: Depreciation and amortization — ( 2,017 )
+Added: Acquired intangible assets ( 2,220 ) ( 3,981 )
+Added: Right-of-use assets ( 2,073 ) ( 2,266 )
+Added: Deferred compensation ( 331 ) —
+Added: Total deferred tax liabilities $ ( 4,624 ) $ ( 8,264 )
+Added: Net deferred tax asset $ 271 $ 156
In assessing the realizability of the Company's deferred tax asset, the Company considers all relevant positive and negative evidence in determining whether it is more likely than not that some portion or all of the deferred income tax assets will not be realized.
1 unchanged sentence
In 2008, the Company established a full valuation allowance against the Company's U.S.
−Removed: deferred tax asset, and although the Company has achieved cumulative of U.S.
−Removed: pre-tax earnings based on a rolling three year window the Company has not achieved a level of sustained profitability that would, in the Company's judgement, support the release of the valuation allowance.
+Added: deferred tax asset.
+Added: The Company has not achieved a level of sustained profitability that would, in the Company's judgment, support the release of the valuation allowance.
Management believes the full valuation allowance is still appropriate as of December 31, 2025 and 2024.
3 unchanged sentences
None of these NOL carryforwards have an expiration date.
−Removed: The Company's foreign NOL carryforwards consist of $ 63.0 million of acquired NOL carryforwards.
−Removed: These foreign NOL carryforwards do not have an expiration date.
+Added: The Company does not have any foreign NOL carryforwards as of December 31, 2025.
+Added: As of December 31, 2024, the Company's foreign NOL carryforwards consisted of $ 63.0 million of acquired NOL carryforwards.
+Added: The foreign NOLs were reduced to zero due to loss limitation rules.
The Company's state NOL carryforwards consist of $ 57.6 million from existing business along with $ 7.2 million of acquired NOL carryforwards.
4 unchanged sentences
Non-Expiring 14,350
−Removed: The Tax Reform Act of 1986 contains provisions under Internal Revenue Code (“IRC”) Section 382 that limit the annual amount of federal and state NOL carryforwards that can be used in any given year in the event a significant change in ownership.
+Added: The Tax Reform Act of 1986 contains provisions under Internal Revenue Code (“IRC”) Section 382 and Section 383 that limit the annual amount of federal and state NOL carryforwards and tax credits that can be used in any given year in the
+Added: event a significant change in ownership.
The Company does not believe that there is a Section 382 limitation that will impair the Company's future ability to utilize NOLs to offset the Company's future taxable income.
The Company continues to review ownership changes on an annual basis and the Company does not believe it has had a subsequent ownership change that would impact the NOLs.
−Removed: The Company acquired 382 limited NOL carryforwards as part of its acquisition of Sherlock.
+Added: The Company acquired 382 limited NOL carryforwards as part of its acquisition of BioMedomics.
These NOL carryforwards have no expiration date.
−Removed: In January 2022, approximately $ 65.0 million was repatriated from the Company's Canadian subsidiary as a one-time event.
−Removed: Associated with this repatriation the Company paid $ 1.7 million in Canadian withholding tax which is included in the Company's foreign income tax expense within the table further above.
+Added: The Company has not undertaken any formal 382 or 383 studies that would indicate any limitations to its NOL or credit carryforwards.
+Added: However, any such study could potentially limit the NOL and credit carryforwards of the Company.
It is still the Company's intention to continue to permanently reinvest the historical undistributed earnings of the Company's foreign subsidiary to the extent that the Company will not incur any additional tax expense associated with foreign withholding or other local tax expense on the future cash transfers.
2 unchanged sentences
operations, the recognition of any tax benefit would not impact the Company's effective tax rate.
+Added: The 2025 addition of $ 1.7 million is not offset by the valuation allowance and its reversal would impact the Company’s effective tax rate.
The Company records interest and penalties related to unrecognized tax benefits as a component of income tax expense.
−Removed: Interest and penalties were immaterial in 2024, 2023, and 2022.
+Added: Interest and penalties were $ 0.2 million in 2025, and immaterial in 2024 and 2023.
As a result of the Company's NOL carryforward position, the Company has been subject to audit by the Internal Revenue Service since the Company's inception, as well as by several jurisdictions for the years ended September 30, 1998 through December 31, 2025.
12 unchanged sentences
As of December 31, 2025, 5,959 shares were available for future grants under the Stock Plan.
−Removed: Under the terms of the Stock Plan, nonqualified stock options may be granted to eligible employees, including the Company's officers at a price not less than 75 percent of the fair market value of a share of common stock on the date of
+Added: Under the terms of the Stock Plan, nonqualified stock options may be granted to eligible employees, including the Company's officers at a price not less than 75 percent of the fair market value of a share of common stock on the date of grant.
The option term and vesting schedule of such awards may be either unlimited or have a specified period in which to vest and be exercised.
63 unchanged sentences
The Company grants performance-based restricted stock units (“PSUs”) to certain executives.
−Removed: Vesting of these PSUs is dependent upon achievement of certain performance-based metrics during a one-year or three-year period, from the date of grant.
+Added: Vesting of these PSUs is dependent upon achievement of certain performance-based metrics during a three-year period, from the date of grant.
Assuming achievement of each performance-based metric, the executive must also generally remain in the Company's service for three years from the grant date.
17 unchanged sentences
In connection with the vesting of performance stock units during the year ended December 31, 2025, 2024 and 2023, the Company purchased and immediately retired 201 , 23 , and 86 shares with aggregate values of $ 0.6 million, $ 0.2 million and $ 0.5 million, respectively.
−Removed: Share Repurchase Program
−Removed: On August 5, 2008, the Company's Board of Directors approved a share repurchase program pursuant to which the Company is permitted to acquire up to $ 25.0 million of the Company's outstanding common shares.
−Removed: No shares were purchased and retired during the years ended December 31, 2024, 2023, and 2022.
−Removed: TRANSITION COSTS
−Removed: On December 31, 2021, the Company's Board of Directors approved the termination of Stephen S.
−Removed: Tang, the Company’s President and Chief Executive Officer, without cause under his existing employment agreement with the Company, with such termination effective as of March 31, 2022.
−Removed: On January 2, 2022, Dr.
−Removed: Tang and the Company entered into a Transition Agreement providing for the terms of the cessation of Dr.
−Removed: Tang’s employment with the Company, including the cessation of his service as President and Chief Executive Officer of the Company and as a member of the Board.
−Removed: Under the Transition Agreement, Dr.
−Removed: Tang’s service to the Company in all capacities ended on March 31, 2022.
−Removed: Pursuant to the Transition Agreement, Dr.
−Removed: Tang received severance of $ 1.6 million, which was accrued in the consolidated financial statements at December 31, 2021 and paid in April 2022.
−Removed: Additionally, in accordance with his Transition Agreement, certain of his unvested time-vesting restricted stock awards and unvested PSUs that were outstanding at March 31, 2022 vested on April 8, 2022.
−Removed: His remaining unvested time-vesting restricted stock awards and PSUs were forfeited on March 31, 2022.
−Removed: These payments, rights and benefits are substantially similar to the severance benefits contemplated by his previous employment agreement in respect to a termination without cause thereunder.
−Removed: In aggregate, the Company recognized $ 1.5 million of expense in relation to Dr.
−Removed: Tang's stock compensation for the year ended December 31, 2022.
+Added: Stock Repurchase Program
+Added: In March 2025, the Company's Board of Directors approved a stock repurchase program effective March 21, 2025, whereby the Company may purchase up to $ 40.0 million in shares of its common stock over a period of up to two years.
+Added: The amount and timing of share repurchases under the program may be carried out at the discretion of the Company's management through various methods in compliance with applicable state and federal laws.
+Added: For the year ended December 31, 2025, 5.3 million shares, totaling $ 15.0 million , were purchased and retired.
BUSINESS SEGMENT INFORMATION:
1 unchanged sentence
All products and services reside under the same reporting hierarchy.
−Removed: Historically, there was separate management leading the Company's Diagnostics and Molecular Solutions businesses.
−Removed: In February 2023, the Company announced a corporate restructuring to combine the commercial and innovation teams across the Diagnostics and Molecular Solutions businesses into one operating segment with sales, marketing, product development and research teams covering all product lines and reporting to a Chief Product Officer ("CPO").
The Company's reportable segment derives its revenues from the sale of diagnostics products and sample management solutions, as described in Note 2 Summary of Significant Accounting Policies.
29 unchanged sentences
Change in the estimated fair value of acquisition-related contingent consideration 4,570 — ( 99 )
+Added: Gain on sale of assets ( 725 ) — —
Operating (loss) income ( 71,969 ) ( 28,250 ) 32,684
−Removed: Other (expense) income (1)
+Added: Other income (expense) (1)
229 ( 380 ) 17,836
2 unchanged sentences
( 924 ) 1,160 ( 124 )
−Removed: (Loss) income before income taxes ( 16,001 ) 56,258 ( 15,675 )
+Added: (Loss) income before income taxes and equity investment ( 64,586 ) ( 16,001 ) 56,258
Income tax expense 1,801 1,799 2,603
21 unchanged sentences
BUSINESS COMBINATIONS:
+Added: On November 12, 2025, the Company acquired all of the outstanding stock of BioMedomics, pursuant to the terms of an acquisition agreement (the "Acquisition Agreement").
+Added: The Company began operating this entity as of the November 12, 2025 closing date.
+Added: The primary reason for the acquisition of BioMedomics was to expand the Company's diagnostic portfolio by adding SickleSCAN ® , a rapid, point-of-need test for sickle cell disease that is sold outside of the United States.
+Added: The initial aggregate purchase price of this transaction was funded with cash on hand as shown in the table below:
+Added: Cash paid to BioMedomics $ 2,865
+Added: Transaction expenses 403
+Added: Debt paid off 330
+Added: Earnout contingent consideration 325
+Added: Expense fund 40
+Added: Initial aggregate purchase price $ 3,963
+Added: Pursuant to the Acquisition Agreement, the Company agreed to pay up to $ 5.0 million of contingent consideration based on the achievement of sales thresholds before December 31, 2031 as defined in Acquisition Agreement.
+Added: The acquisition-date fair value of the earnout contingent consideration was $ 0.3 million.
+Added: The range of outcome for the earnout contingent consideration is zero to $ 5.0 million.
+Added: During the year ended December 31, 2025, the Company incurred a total of $ 0.5 million of acquisition related costs, including accounting, legal, and other professional fees, all of which were expensed and reported as a component of general and administrative expenses in the consolidated statement of operations for the year ended December 31, 2025.
+Added: The following table summarizes the estimated fair values of the assets acquired and liabilities assumed as of the acquisition date:
+Added: Assets Acquired
+Added: Other current and non current assets $ 10
+Added: Inventory 284
+Added: Operating right-of-use assets 120
+Added: Developed technology intangible asset 1,900
+Added: Goodwill 1,775
+Added: Total assets acquired 4,089
+Added: Liabilities Assumed
+Added: Accounts payable 34
+Added: Current liabilities 17
+Added: Deferred revenue 72
+Added: Operating lease liability 120
+Added: Total liabilities assumed 243
+Added: Net Assets Acquired 3,846
+Added: Estimated fair value of contingent consideration ( 233 )
+Added: Net Cash Paid (net of cash acquired of $ 25 )
+Added: The purchase price was allocated to the tangible assets and identifiable intangible asset acquired and liabilities assumed based on their acquisition-date estimate fair values.
+Added: The identifiable intangible asset was developed technology.
+Added: The developed technology was all assigned a ten year useful life.
+Added: The Company, with the assistance of an independent valuation specialist, assessed the fair value of the intangible asset and contingent consideration of BioMedomics.
+Added: The fair values recorded as of November 12, 2025 are based on significant inputs that are not observable in the market and thus represent a fair value measurement categorized within Level 3 of the fair value hierarchy.
+Added: The fair value of the acquired developed technology was determined using the multi-period excess earnings method, which required judgment in estimating appropriate cashflows, discount rate, survival factor, and remaining useful life.
+Added: The fair value of the earnout contingent consideration was determined using the Monte Carlo simulation model, which require judgment in estimating expected revenue, volatility, expected discount rate and risk-free interest rate.
+Added: Goodwill is calculated as the difference between the acquisition date fair value of the consideration transferred and the fair value of the net assets acquired, and represents the future economic benefits that we expect to achieve as a result of the acquisition.
+Added: The Company believes the goodwill related to the acquisition was a result of BioMedomics providing a product that will enable the Company to leverage the products with existing and new customers.
+Added: The goodwill is not deductible for income tax purposes.
+Added: The Company continues to evaluate the fair value of assets acquired and liabilities assumed.
+Added: Additional information, which existed as of the acquisition date, but was at that time unknown to the Company, may become known during the remainder of the measurement period.
+Added: Changes to amounts recorded as a result of the final determination may result in a corresponding adjustment to these assets and liabilities, including goodwill.
+Added: The determination of the estimated fair values of all assets acquired is expected to be completed within one year from the date of acquisition.
+Added: Revenues from BioMedomics consist of sales from the SickleSCAN ® test.
+Added: Effective as of November 12, 2025, the financial results of BioMedomics are included in the consolidated financial results of the Company.
+Added: BioMedomics contributed $ 0.1 million and $ 1.1 thousand of revenue and net income, respectively, to the consolidated statement of operations for the year ended December 31, 2025.
+Added: Unaudited Pro Forma Financial Information
+Added: The unaudited pro forma results presented below include the results of the BioMedomics acquisition as if it had been consummated as of January 1, 2024.
+Added: The unaudited pro forma results include, amortization of the acquired intangible assets, stock compensation, and lease expense adjustments to income before income taxes but do not include changes in the fair value of the Company's contingent consideration obligations.
+Added: Material nonrecurring charges, directly attributable to the transactions, including direct acquisition costs, are also excluded.
+Added: In addition, the unaudited pro forma results do not include any expected benefits of the acquisitions.
+Added: Accordingly, the unaudited pro forma results are not necessarily indicative of either future results of operations or results that might have been achieved had the acquisitions been consummated as of January 1, 2024.
+Added: For the Years Ended December 31,
+Added: Net revenues $ 115,797 $ 187,041
+Added: $ ( 68,964 ) $ ( 20,889 )
Sherlock Biosciences
1 unchanged sentence
The Company began operating this entity as of the December 19, 2024 closing date.
−Removed: The primary reason for the acquisition is Sherlock's first test for Chlamydia Trachomatis (CT) and Neisseria Gonorrhoeae (NG) is in clinical studies and is expected to be submitted to the FDA for approval by the end of 2025.
+Added: The primary reason for the acquisition was Sherlock's first test for Chlamydia Trachomatis (CT) and Neisseria Gonorrhoeae (NG), which is in clinical studies and was submitted to the FDA in late 2025.
Subject to regulatory approvals, this test is expected to expand the Company's portfolio for rapid diagnostics for sexually transmitted infections.
−Removed: The initial aggregate purchase price of this transaction was funded with cash on had as shown below:
+Added: The initial aggregate purchase price of this transaction was funded with cash on hand as shown in the table below:
Milestone contingent consideration $ 15,910
5 unchanged sentences
Pursuant to the Merger Agreement, the Company agreed to pay up to $ 20.0 million of contingent consideration based on the achievement of a regulatory milestone on or before December 31, 2026 as defined in the Merger Agreement.
−Removed: The fair value of this milestone metric contingent consideration was $ 15.9 million.
−Removed: The range of outcome for the milestone contingent consideration is $ 0.0 million to $ 20.0 million.
−Removed: Also, there is a mid-single digits quarterly royalty fee based on future sales until 2034 as defined in the Merger Agreement, which was fair valued as part of contingent consideration.
+Added: The acquisition-date fair value of the milestone contingent consideration was $ 15.9 million.
+Added: The range of outcome for the milestone contingent consideration is zero to $ 20.0 million.
+Added: There is also a mid-single digits quarterly royalty fee based on future sales until 2034 as defined in the Merger Agreement, the fair value of which was determined as part of the contingent consideration.
The estimated acquisition-date fair value of the royalty fee acquisition-related contingent consideration was $ 7.0 million.
−Removed: The range of outcome for the royalty payment cannot be determined due to the fact its based on future sales associated with the acquired in-process research and development technology through 2034 and thus does not have an upper limit.
+Added: The range of outcome for the royalty payment cannot be determined due to the fact it is based on future sales associated with the acquired in-process research and development technology through 2034 and thus does not have an upper limit.
During the year ended December 31, 2024, the Company incurred a total of $ 1.0 million of acquisition related costs, including accounting, legal, and other professional fees, all of which were expensed and reported as a component of general and administrative expenses in the consolidated statement of operations for the year ended December 31, 2024.
23 unchanged sentences
Projected cash flows are discounted at a required rate of return that reflects the relative risk of achieving the cash flows and the time value of money.
−Removed: The regulatory milestone scenario based model was used to value the assumed milestone contingent consideration, were primarily based on significant unobservable inputs and are considered Level 3 fair value measurements.
+Added: The regulatory milestone scenario based model was used to value the assumed milestone contingent consideration, and the fair value measurements were primarily based on significant unobservable inputs and are considered Level 3 fair value measurements.
The regulatory milestone scenario based model estimates fair value for contingent consideration based on the probability of on the achievement of a certain milestone as defined under the agreements and the discount rate.
−Removed: The fair value of contingent payments approach was used to value the royalty based contingent consideration, were primarily based on significant unobservable inputs and are considered Level 3 fair value measurements.
−Removed: The fair value of contingent payments approach were primarily based on projected cash flows, probability of on the achievement of a regulatory milestone as defined under the agreements, and discount rate.
+Added: The income approach was used to value the royalty based contingent consideration, and the fair value measurements were primarily based on significant unobservable inputs and are considered Level 3 fair value measurements.
+Added: The fair value of contingent payments approach was primarily based on projected cash flows, probability of on the achievement of a regulatory milestone as defined under the agreements, and discount rate.
Goodwill is calculated as the difference between the acquisition date fair value of the consideration transferred and the fair value of the net assets acquired, and represents the future economic benefits that we expect to achieve as a result of the acquisition.
1 unchanged sentence
The goodwill is not deductible for income tax purposes.
−Removed: The Company continues to evaluate the fair value of certain assets acquired and liabilities assumed.
−Removed: Additional information, which existed as of the acquisition date, but was at that time unknown to the Company, may become known during the remainder of the measurement period.
−Removed: Changes to amounts recorded as a result of the final determination may
−Removed: result in a corresponding adjustment to these assets and liabilities, including goodwill.
−Removed: The determination of the estimated fair values of all assets acquired is expected to be completed within one year from the date of acquisition.
+Added: The Company has completed the fair value of the assets acquired and liabilities assumed.
Revenues from Sherlock primarily consist of grant revenues for research and development purposes.
Effective as of December 19, 2024, the financial results of Sherlock are included in the consolidated financial results of the Company.
−Removed: For the year ended December 31, 2024, consolidated net revenues include revenues associated with Sherlock of $ 78.0 thousand and consolidated results from operations include a net loss of $ 255.4 thousand generated since the acquisition date.
Unaudited Pro Forma Financial Information
7 unchanged sentences
Net income loss $ ( 41,459 ) $ 7,992
−Removed: COMMITMENTS AND CONTINGENCIES:
−Removed: Purchase Commitments
−Removed: As of December 31, 2024, the Company had a manufacturing agreement with a third party vendor requiring a minimum purchase commitment.
−Removed: If the minimum commitment is not achieved, the Company will be required to make annual penalty payments over the next year.
−Removed: Based on current forecasts, these penalties aggregate to approximately $ 0.3 million and are accrued for in the consolidated balance sheet.
−Removed: These estimated penalties can fluctuate based on changes in forecasted demand.
−Removed: The table below represents an estimate of future purchases under the agreement (in thousands):
+Added: CONTINGENCIES:
Collaborations
−Removed: Sherlock has an active third-party license agreement entered into in order to advance and obtain technologies and services related to the business.
−Removed: Under this license, the Company is required to make up to $ 2.3 million of cash payments upon the achievement of certain scientific and commercial milestones as well as low single digit royalty payments on product sales.
−Removed: No milestone payments have been made as of December 31, 2024.
−Removed: The Company has the right to terminate the license for any reason.
−Removed: Unless otherwise terminated, the license terminates upon the expiration of the last to expire valid claim.
+Added: Sherlock has active third-party license agreements entered into in order to advance and obtain technologies and services related to the business.
+Added: Under these licenses, the Company is required to make up to $ 3.8 million of cash payments upon the achievement of certain scientific and commercial milestones as well as low single digit royalty payments on product sales.
+Added: The Company has the right to terminate the licenses.
From time to time, the Company is involved in certain legal actions arising in the ordinary course of business.
In management’s opinion, based upon the advice of counsel, the outcomes of such actions are not expected, individually or in the aggregate, to have a material adverse effect on the Company's future financial position or results of operations.
−Removed: Spectrum Patent Litigation
−Removed: In March 2021, the Company filed a complaint against Spectrum Solutions, LLC (“Spectrum”) in the United States District Court for the Southern District of California alleging that certain saliva collection devices manufactured and sold by Spectrum infringe a patent held by DNAG.
−Removed: Spectrum filed an answer asserting that its device does not infringe the Company’s patent and that the Company’s patent is invalid.
−Removed: In August 2021, the Company amended its complaint to add a second patent to this litigation.
−Removed: Spectrum responded to the Company's amended complaint and asserted counterclaims for inequitable conduct and antitrust violations with respect to one of the patents in the litigation and subsequently filed a request for review of the second patent at the Patent and Trademark Office (“PTO”), which was granted by the PTO.
−Removed: The District Court issued multiple pretrial orders, resolving the infringement, antitrust, and inequitable conduct claims without trial.
−Removed: First, the District Court granted Spectrum’s motion for summary judgment of noninfringement.
−Removed: Second, the Court denied Spectrum’s motion to supplement its allegations of alleged antitrust violations, finding that if such an amendment were allowed, Spectrum’s claims would not survive a motion for summary judgment.
−Removed: Spectrum thereafter withdrew its antitrust and inequitable conduct counterclaims.
−Removed: Spectrum did not appeal the District Court's denial of its motion to amend.
−Removed: The Company appealed the grant of summary judgment to the Court of Appeals on June 8, 2023.
−Removed: On February 14, 2025, the Court of Appeal affirmed the District Court’s judgment.
−Removed: The Company is considering its appellate options.
−Removed: On February 7, 2024, the PTO issued a Final Written Decision regarding the second patent in the litigation, holding that claims 1, 3–8, 11, and 12 of U.S.
−Removed: 11,002,646 B2 are unpatentable.
−Removed: On March 8, 2024, the Company filed a Request for Rehearing by the Director of the PTO of the Final Written Decision.
−Removed: On March 27, 2024, the Company’s Request for Rehearing was denied.
−Removed: On September 15, 2023, Spectrum filed a separate petition for inter partes review of a third patent, which DNAG did not assert in the District Court.
−Removed: On March 26, 2024, the PTO issued a Decision Granting Institution of Inter Partes Review.
−Removed: On July 2, 2024, the Company filed a Motion to Amend the claims of the third patent and oral argument in this IPR took place on January 24, 2025.
−Removed: On February 19, 2025, the PTO issued a Final Written Decision regarding the third patent in the litigation, granting the Company's Motion to Amend as to cancelling the original claims,
−Removed: but denying the Company's Motion to Amend as to adding proposed substitute claims.
−Removed: The Company is considering its appellate options.
−Removed: NowDiagnostics Litigation
On November 14, 2024 the Company filed a complaint against NowDiagnostics, Inc.
4 unchanged sentences
NowDx, Berry, and Young agreed to a preliminary injunction which the Court entered on February 27, 2025.
+Added: The case is currently in the discovery phase and the schedule for any further proceedings is currently pending.
RETIREMENT PLANS:
9 unchanged sentences
As of December 31, 2025 and 2024, the value of the assets associated with this plan was $ 0.5 million and $ 0.7 million, respectively, and is included in other current assets and other noncurrent assets in the Company's consolidated balance sheets.
−Removed: The Company's obligation related to the deferred compensation plan is included in accrued expenses and other noncurrent liabilities in the Company's consolidated balance sheets.
+Added: The Company's obligation related to the deferred compensation plan is included in accrued expenses and other
+Added: noncurrent liabilities in the Company's consolidated balance sheets.
As of December 31, 2025 and 2024, the Company's total obligation under this plan was $ 0.5 million and $ 0.7 million, respectively.
3 unchanged sentences
The Company contributed $ 0.3 million, $ 0.4 million and $ 0.4 million to the RRSP in 2025, 2024, and 2023, respectively.
+Added: Substantially all British employees are eligible to participate in the People's Pension Plan (the “PPP”).
+Added: The PPP permits voluntary employee contributions which may be excluded from an employee’s current taxable income and receive tax-preferred treatment with HM Revenue and Customs.
+Added: The PPP also provides for the Company to match employee contributions.
+Added: The Company contributed $ 0.1 million to the PPP in 2025.
+Added: SUBSEQUENT EVENTS:
+Added: In February 2026, the Company terminated certain non-production employees, which was less than 10 % of its work force.
+Added: The termination was to align the Company's cost structure.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.