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• The Company's future success depends upon market acceptance of its existing and future products and service offerings.
−Removed: • The Company may not realize revenue levels from its InteliSwab® COVID-19 Rapid Test consistent with prior years.
−Removed: • Marketing of the Company's COVID-19 tests and collection kits under EUAs from the FDA is subject to certain limitations and it is required to maintain compliance with the terms of the EUA, among other things, and the continuance of the EUAs is subject to government discretion.
• If acceptance and adoption of oral fluid testing and collection products does not continue, the Company's future results may suffer.
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Regulatory Risks
+Added: • Delay or failure to obtain FDA approval for new products could delay commercialization of new products and prevent the Company from achieving revenue growth.
• The need to obtain regulatory approvals, clearances, authorizations or certifications could increase the Company's costs and adversely affect its financial performance.
6 unchanged sentences
Risks Relating to the Company's Common Stock
−Removed: • The Company's stock price could continue to be volatile.
+Added: • The Company's stock price could be volatile.
General Risk Factors
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These trends in the ancestry testing market may continue and revenues in this market may continue to be volatile.
−Removed: In an effort to increase the Company's molecular revenues, it has devoted increasing time and attention to expanding sales of its genomics products both domestically and internationally, with both new and existing accounts, including co-clearances and co-promotions with strategic partners.
+Added: In an effort to increase the Company's molecular revenues, it has devoted increasing time and attention to expanding sales of its genomics products both domestically and internationally, with both new and existing accounts, including co-
+Added: clearances and co-promotions with strategic partners.
While the Company believes these new markets represent large growth opportunities, there is no assurance that it will be successful in capitalizing on these opportunities or that it will be able to increase the Company's product sales consistent with the Company's expectations.
−Removed: Factors include, but are not limited to, the market acceptance of the Company's products, available funding, cost containment strategies implemented by customers, increasing competition and regulatory constraints could limit sales of the Company's genomics products.
+Added: Factors that may impact the success of our genomics products include, but are not limited to, the market acceptance of the Company's products, available funding, cost containment strategies implemented by customers, increasing competition and regulatory constraints could limit sales of the Company's genomics products.
To the extent that the Company is unsuccessful or limited in expanding the its business into new markets, the Company's revenues and results of operations could be negatively affected.
−Removed: Despite these challenges, the Company believes there is significant growth opportunity for its genomics products in the area of research by biotechnology companies, animal genetics, and disease risk management, which includes genetic risk testing, prenatal testing, carrier screening, pharmacogenomics testing and population heath studies.
The Company's Future Success Depends Upon Market Acceptance of its Existing and Future Products and Service Offerings.
−Removed: The Company's future success will depend, in part, on the market acceptance, and the timing of such acceptance, of products such as InteliSwab ® , OraQuick ® HIV Self-Test, OraQuick ® Ebola test and OMNIgene ® • GUT product offerings, and other new products or technologies that may be developed or acquired.
−Removed: In addition, the Company's future revenues will depend on market acceptance of new uses for the Company's saliva collection products, and the Company's new service offerings, such as Syphilis Health Check ® and OraQuick ® HCV Self-Test.
+Added: The Company's future success will depend, in part, on the market acceptance, and the timing of such acceptance, of existing products and products or technologies that may be developed or acquired.
+Added: In addition, the Company's future revenues will depend on market acceptance of urine as a sample type , and the Company's other product offerings, such as the Company's anticipated CT/NG test and Colli-Pee ® device.
To commercially market new uses of the Company's products and to achieve market acceptance, it will likely be required to undertake clinical studies to validate the new uses for its products and spend significant funds to complete product development and clinical studies and then undertake substantial marketing efforts to inform potential customers and the public of the existence and perceived benefits of these products and services.
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The market for microbiome products and services is in its early stages and its future development and acceptance by the Company's customers is uncertain.
−Removed: Also, the Company continues to develop and seek 510(k) regulatory clearance for the InteliSwab® tests, and it is uncertain whether it will be successful in the development and validation efforts or whether these products will prove effective, receive applicable regulatory approvals and gain widespread acceptance in the marketplace.
As such, there can be no assurance that any products or services will obtain significant market acceptance and fill the market need that is perceived to exist on a timely basis, or at all.
−Removed: It is possible that the Company's expenses to develop and market any such products, including, without limitation the Company's InteliSwab ® tests, will exceed any benefit in revenues, which may be short-lived.
+Added: It is possible that the Company's expenses to develop and market any such products will exceed any benefit in revenues, which may be short-lived.
In addition, other products that compete with the Company's may achieve 510(k) clearance earlier than the Company's do, providing market advantages.
−Removed: The Company Expects Revenue Levels From its InteliSwab® COVID-19 Rapid Test to Continue to Decline .
−Removed: The Company experienced a significant decline in revenues from InteliSwab ® COVID-19 Rapid Test sales in 2024 and expects revenues to continue to decline in 2025.
−Removed: The Company has seen a reduction in the prevalence of COVID-19 since the height of the pandemic, particularly following the expiration of the public health emergency declarations related to COVID-19 in mid-2023.
−Removed: The Company's revenues relating to the Company's COVID-19 testing products have declined, and it expects they will continue to decline in the future if the prevalence of COVID-19 remains low.
−Removed: Further, if the COVID-19 pandemic becomes a seasonal virus or experiences fluctuations in prevalence, the Company could experience fluctuations in its revenues associated with its InteliSwab® COVID-19 Rapid Tests.
−Removed: While there is still limited demand for COVID-19 testing products, there is no guarantee that current or anticipated demand will continue, or if demand does continue, that the Company will be able to produce its InteliSwab® COVID-19 Rapid Test in quantities to meet the demand.
−Removed: A significant decline in demand for the InteliSwab ® COVID-19 Rapid Test without a corresponding increase in the Company's other businesses could have a material, adverse effect on the Company's results of operations, cash flow and financial position.
−Removed: Marketing of the Company's COVID-19 Tests and Collection Kits Under EUAs from the FDA Is Subject To Certain Limitations and the Company Is Required To Maintain Compliance with the Terms of the EUA, Among Other Things, and the Continuance of the EUAs Is Subject To Government Discretion.
−Removed: In early 2020, the HHS issued a declaration that the threat to public health posed by COVID-19 justifies the emergency use of unapproved in vitro diagnostics for the detection or diagnosis of SARS-CoV-2.
−Removed: Under Section 564 of the FDCA, because HHS has issued this declaration, the FDA Commissioner is authorized to issue EUAs to permit certain developers of SARS-CoV-2 diagnostics to begin offering the tests for detection and diagnosis of COVID-19 without having completed the normally applicable FDA review and clearance or approval process for marketing authorization (with the related standards that would apply to demonstrate safety and effectiveness).
−Removed: The issuance of an EUA reflects an FDA conclusion that based on the totality of scientific evidence available to the FDA, it is reasonable to believe that the product may be effective in diagnosing COVID-19, the known potential benefits of the product outweigh the known and potential risks, and there is no adequate, approved, and available alternative to the emergency use of the product.
−Removed: During 2020, the Company's ORAcollect ® ·RNA and OMNIgene ® ·ORAL collection devices were included in EUAs granted by the FDA to certain third parties for use in the detection of SARS-CoV-2, and the Company has separately obtained EUAs for these products.
−Removed: In addition, the Company obtained three EUAs for its new InteliSwab® COVID-19 Rapid Test.
−Removed: Although there are certain regulatory requirements the FDA has waived for the duration of the EUAs, the Company remains subject to specific conditions of the authorization, including ensuring appropriate labeling as approved by FDA specifically for purposes of the EUA, maintaining records of distribution to authorized laboratories, collecting data on occurrences of any false positives or false negatives, and tracking any adverse events.
−Removed: As part of the conditions of authorization, OraSure was required to conduct a clinical study in a pediatric population ages 2-14 and an asymptomatic population in addition to launching an app for consumers to report their test results to public health jurisdictions.
−Removed: OraSure has completed the required conditions of authorization with respect to the pediatric claim and launched the InteliSwab® Connect application for reporting test results to public health jurisdictions.
−Removed: As a result of the National Institutes of Health study (Performance of Screening for SARS-CoV-2 using Rapid Antigen Tests to Detect Incidence of Symptomatic and Asymptomatic SARS-CoV-2 Infection:
−Removed: findings from the Test Us at Home prospective cohort study), the FDA has requested modifications to labeling to include serial testing and has removed the requirement for the Company to conduct a study in an asymptomatic population.
−Removed: Labeling has been modified as required for inclusion of serial testing and authorized by FDA.
−Removed: As with other FDA-regulated products, issues could emerge during the course of the marketing and use of the Company's products under an EUA that could impact the Company's ability to continue the sale and distribution of these products (for example, compliance or product performance issues).
−Removed: The applicable EUAs remain effective only until the HHS declaration is terminated or revoked, and the FDA may also revoke an EUA if it determines the criteria for issuance are no longer met or other circumstances make such revocation appropriate to protect the public health or safety.
−Removed: If that were to occur, then in order to market the Company's diagnostic products or collection kits for the purpose of detecting COVID-19 the Company would be required to obtain the necessary regulatory clearances or approvals and be subject to the full and usual regulatory obligations for device manufacturers, including the QSR under 21 CFR Part 820.
−Removed: It is possible that the Company may not be able to obtain those clearances or approvals in a timely manner, or at all, and that one or more of OraSure's competitors may obtain the necessary clearances or approvals for their products before the Company does.
If Acceptance and Adoption of Oral Fluid Testing and Collection Products Does Not Continue, the Company's Future Results May Suffer.
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As a result, there can be no assurance that the Company will be able to expand the use of its oral fluid testing products in these or other markets.
−Removed: However, clinical reference laboratories and hospital-based laboratories currently provide the majority of diagnostic tests used by physicians and other healthcare providers in the U.S.
+Added: Clinical reference laboratories and hospital-based laboratories currently provide the majority of diagnostic tests used by physicians and other healthcare providers in the U.S.
In certain international markets such as Europe, diagnostic testing is performed primarily by centralized laboratories.
The Company's future sales will depend, in part, on the Company's ability to expand market acceptance of rapid point-of-care testing by physicians, other healthcare providers and consumers and successfully compete against laboratory testing methods and products.
−Removed: Even if the Company can
−Removed: demonstrate that its products are more cost effective, save time, or have better performance or other benefits, physicians, other healthcare providers and consumers may resist changing to rapid point-of-care tests and instead may choose to obtain diagnostic results through laboratory tests.
+Added: Even if the Company can demonstrate that its products are more cost effective, save time, or have better performance or other benefits, physicians, other healthcare providers and consumers may resist changing to rapid point-of-care tests and instead may choose to obtain diagnostic results through laboratory tests.
The Company's failure to achieve and expand market acceptance of its rapid point-of-care diagnostic tests with customers would have a negative effect on its future sales growth.
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This competition is particularly evident with respect to the Company's OraQuick ADVANCE ® HIV-1/2 test and the Company's HIV Self-Test outside of the United States.
−Removed: The Oragene ® product line sold by the Company's subsidiary, DNAG, competes against other sample management solutions, such as blood collection kits and buccal swabs and will likely face additional competition from collection devices similar in design and operation to the Company's Oragene ® and ORAcollect ® products.
+Added: The Oragene ® product line sold by the Company's subsidiary, DNAG, competes against other sample management solutions, such as blood collection kits and buccal swabs and will likely face additional competition from collection devices similar in design and operation to the Company's Oragene ® and
+Added: ORAcollect ® products.
Additionally, there are a number of products for the detection of antigen to SARS-CoV-2 that compete with the Company's InteliSwab ® COVID-19 diagnostic test.
−Removed: There is significant competition, including from other companies and governmental organizations, who make and distribute rapid tests for COVID-19.
−Removed: Many of these entities have substantially greater resources (including capital and personnel) than OraSure does.
−Removed: Even if the Company is successful in marketing its InteliSwab® tests, there is no guarantee that competitors will not take market share from the Company's offerings through more effective marketing or competitive pricing, higher quality or technological superiority.
A number of the Company's competitors are making investments in competing technologies, products and services, and several may have a competitive advantage because of their greater financial, technical, research and other resources.
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For example, the National Institutes of Health (“NIH”) announced on February 7, 2025, a policy significantly reducing research grants by limiting payments for indirect costs.
−Removed: While, as of the date of this filing, the order has been temporarily stayed, there can be no assurance that it will not take effect or that other adverse actions will not be taken.
+Added: While, as of the date of this filing, a lower court has imposed a permanent injunction preventing the NIH from adopting the policy, which as been subsequently affirmed by a U.S.
+Added: Circuit Court of Appeals, there can be no assurance that further adverse actions will not be taken.
Further, our revenue may be adversely affected if our clients delay purchases as a result of uncertainties surrounding the approval of government budget proposals, including reduced allocations to government agencies.
In addition, government funding is subject to the political process, which is inherently fluid and unpredictable.
−Removed: As a result, the Company may expend considerable resources on unsuccessful sales efforts or it
−Removed: may not be able to complete transactions at all or on a schedule and in an amount consistent with its objectives or previous order patterns.
+Added: As a result, the Company may expend considerable resources on unsuccessful sales efforts or it may not be able to complete transactions at all or on a schedule and in an amount consistent with its objectives or previous order patterns.
The Company's Inability To Expand International Sales Could Adversely Affect its Business and Results of Operations.
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The Company is also working to expand international sales of its professional HIV and HCV products and its sample management solutions.
+Added: The Company is also pursuing opportunities to obtain certain governmental or economic incentives by establishing in‑country value‑added assembly or manufacturing operations (“near‑shoring”) in select international markets, including in parts of Africa, which are intended to provide cost, logistics, or market-access benefits.
While the Company believes international sales of these and other products represent attractive long-term opportunities with significant growth potential, there is no guarantee that these opportunities will materialize, continue or increase.
4 unchanged sentences
As a result, sales in certain countries may contribute lower profit margins to the Company's business.
−Removed: To the extent these international sales comprise a large or increasing part of the Company's business, the Company's gross margins will be negatively affected.
+Added: To the extent these international sales comprise a large or
+Added: increasing part of the Company's business, the Company's gross margins will be negatively affected.
In addition, the Company may have difficulty selling its products at a sufficiently low price to maintain or increase this business over the long term without funding support from public health entities, government agencies or other sources.
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Historically, the Company has sold a number of its products to the government under contracts with the General Services Administration and the Veterans Administration.
−Removed: In September 2022, the Company entered into an $8.6 million contract with BARDA to develop a second generation Ebola test on the OraQuick ® testing platform, which was subsequently modified in September 2023 to add an additional $6.8 in funding to be used to obtain the appropriate regulatory approvals.
−Removed: Also in September, 2022, the Company was selected to provide its OraQuick ® In-Home HIV tests in support of the CDC "Together Take me Home," HIV self-test program.
+Added: In September 2022, the Company entered into an $8.6 million contract with BARDA to develop an updated Ebola test on the OraQuick ® testing platform, which was subsequently modified in September 2023 to add an additional $6.8 in funding to be used to obtain the appropriate regulatory approvals.
+Added: Also in September, 2022, the Company was selected to provide its OraQuick ® HIV Self-Tests in support of the CDC "Together Take me Home," HIV self-test program.
Under the program, the CDC is expected to provide $41.5 million over a five-year period to support community testing.
−Removed: During the third quarter of 2022, the Company entered into a contract with the Defense Logistics Agency ("DLA") for the second procurement of the Company's InteliSwab ® COVID-19 Rapid Test for OTC use.
−Removed: During the same quarter, the Company entered into a contract with the BARDA to provide it with up to $13.6 million in funding to obtain an FDA 510(k) clearance and CLIA waiver for the Company's InteliSwab® test.
−Removed: The Company continued development work and analytical testing on this test throughout 2023.
−Removed: However, in early 2024, the Company has communicated to BARDA that it does not intend to pursue further development of this product.
−Removed: In September 2021, the Company entered into a contract with the U.S.
−Removed: DOD in coordination with the HHS for $109 million in funding to build additional manufacturing capacity in the United States for the Company's InteliSwab ® test.
As a result of the Company's U.S.
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Factors such as defective materials or processes, mechanical failures, human errors, environmental conditions, changes in materials or production methods, and other events or conditions could cause the Company's products or the materials used to produce or assemble its products to fail inspections and quality testing or otherwise not perform in accordance with their label claims or the expectations of the Company's customers.
−Removed: In February 2024, the FDA issued the Quality Management System Regulation (QMSR) Final Rule to amend the QSR, incorporating by reference the international standard for medical device quality management systems set by the
−Removed: International Organization for Standardization (ISO), ISO 13485:2016.
−Removed: The rule will become effective on February 2, 2026.
−Removed: Until then, manufacturers are required to comply with the QSR.
−Removed: We believe that our facilities and procedures are in material compliance with the FDA’s QSR requirements, the European Union’s Quality Management Systems requirements, ISO 13485:2016, but the regulations are subject to change or may be unclear, and we cannot be sure that FDA investigators will agree with our compliance with the FDA’s post-market requirements.
+Added: We believe that our facilities and procedures are in material compliance with the FDA’s QMSR requirements, the European Union’s Quality Management Systems requirements, ISO 13485:2016, but the regulations are subject to change or may be unclear, and we cannot be sure that FDA investigators will agree with our compliance with the FDA’s post-market requirements.
Any failure or delay in the Company's ability to meet the applicable specifications, performance standards, quality requirements or customer expectations could adversely affect its ability to manufacture and sell its products or comply with regulatory requirements.
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If it experiences production delays or inefficiencies, a deterioration in the quality of the Company's products or other complications in managing changes to its manufacturing processes, including those that are designed to increase capacity, enhance efficiencies and reduce costs or that relate to new products or technologies, the Company may not achieve the benefits that it anticipates from these actions when expected, or at all, and the Company's operations could experience disruptions, the Company's manufacturing efficiency could suffer and the Company's business, financial condition and results of operations could be materially and adversely affected.
−Removed: Any such delays could allow the Company's competitors to seize market advantage, which could have a material, adverse effect on the Company's reputation, revenues, results of operations, cash flow and financial position.
+Added: Any such delays could allow the Company's
+Added: competitors to seize market advantage, which could have a material, adverse effect on the Company's reputation, revenues, results of operations, cash flow and financial position.
The Company's Business Results Depend on Its Ability to Manage Disruptions in Its Domestic and Global Supply Chains and Distribution Channels.
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The Company's transportation and service providers are typically able to pass any significant increases in oil prices on to it.
−Removed: The Company's costs may also be impacted by laws to increase minimum wages,
−Removed: including the potential increase to the federal minimum wage in the United States that has been recently proposed by the current administration.
+Added: The Company's costs may also be impacted by laws to increase minimum wages, including the potential increase to the federal minimum wage in the United States that has been recently proposed by the current administration.
The Company's ability to recover such increased costs may depend upon its ability to raise prices on its products.
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The Company has contracted with third parties in Thailand for parts of the assembly of OraQuick ® HIV device and the OraQuick ® HIV Self-Test in order to supply certain international markets.
−Removed: In addition, the Company's subsidiary, DNAG, uses third-party manufacturers to supply certain products, including its Colli-Pee ® , Oragene ® and ORAcollect ® lines of collection kits.
+Added: In addition, the Company's subsidiary, DNAG, uses, on a limited basis, third-party manufacturers to supply certain products, including its Colli-Pee ® , Oragene ® and ORAcollect ® lines of collection kits.
Any interruption in, or change in the cost or quality of, the supply of the necessary raw materials, manufacturing services, product and process development, or other materials necessary to manufacture the product could adversely impact the efficacy of the product and negatively affect the Company's reputation with its customers.
In addition, many of the raw materials used in the Company's DNAG products, including its Oragene ® product line, and components used in these products are also purchased from third parties, some of which are purchased from a sole-source supplier.
−Removed: If the Company's sole-source suppliers were to be acquired by a competitor, they may elect not to provide it with the product, raw materials or other components, as applicable.
+Added: If the Company's
+Added: sole-source suppliers were to be acquired by a competitor, they may elect not to provide it with the product, raw materials or other components, as applicable.
If the Company's sole-source suppliers were to otherwise cease supplying it, go out of business, or were unable to meet their obligations in a timely fashion or at an acceptable price, or at all, the Company may be forced to incur higher costs to obtain the necessary raw materials elsewhere, if it could even source such materials at all.
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Adjustments arising from government audits and reviews could have a material adverse effect on the Company's business, financial condition, results of operations and prospects.
−Removed: Moreover, if any administrative process or system related to such contracts is found not to comply with governmental requirements, the Company may be subjected to government scrutiny that could delay or otherwise adversely affect its ability to compete for or perform government contracts or collect its revenue in a timely manner.
+Added: Moreover, if any administrative process or system related to such contracts is found not to comply with governmental requirements, the Company may be subjected to government scrutiny that could delay or otherwise adversely affect its
+Added: ability to compete for or perform government contracts or collect its revenue in a timely manner.
An unfavorable outcome of an audit of the Company's government contracts could adversely affect its results of operations.
+Added: The Company Expects Revenue Levels From its InteliSwab ® COVID-19 Rapid Test to Continue to Decline .
+Added: The Company experienced a significant decline in revenues from InteliSwab ® COVID-19 Rapid Test sales in 2024 and 2025, and expects revenues to continue to decline in 2026.
+Added: The Company has seen a reduction in the prevalence of COVID-19 since the height of the pandemic, particularly following the expiration of the public health emergency declarations related to COVID-19 in mid-2023.
+Added: The Company's revenues relating to the Company's COVID-19 testing products have declined, and it expects they will continue to decline in the future if the prevalence of COVID-19 remains low.
+Added: Further, if COVID-19 becomes a seasonal virus or experiences additional fluctuations in prevalence, the Company could experience fluctuations in its revenues associated with its InteliSwab® COVID-19 Rapid Tests.
+Added: While there is still limited demand for COVID-19 testing products, there is no guarantee that current or anticipated demand will continue, or if demand does continue, that the Company will be able to produce its InteliSwab® COVID-19 Rapid Test in quantities to meet the demand.
+Added: Marketing of the Company's COVID-19 Tests and Collection Kits Under EUAs from the FDA Is Subject To Certain Limitations and the Company Is Required To Maintain Compliance with the Terms of the EUA, Among Other Things, and the Continuance of the EUAs Is Subject To Government Discretion.
+Added: In early 2020, the HHS issued a declaration that the threat to public health posed by COVID-19 justifies the emergency use of unapproved in vitro diagnostics for the detection or diagnosis of SARS-CoV-2.
+Added: Under Section 564 of the FDCA, because HHS has issued this declaration, the FDA Commissioner is authorized to issue EUAs to permit certain developers of SARS-CoV-2 diagnostics to begin offering the tests for detection and diagnosis of COVID-19 without having completed the normally applicable FDA review and clearance or approval process for marketing authorization (with the related standards that would apply to demonstrate safety and effectiveness).
+Added: The issuance of an EUA reflects an FDA conclusion that based on the totality of scientific evidence available to the FDA, it is reasonable to believe that the product may be effective in diagnosing COVID-19, the known potential benefits of the product outweigh the known and potential risks, and there is no adequate, approved, and available alternative to the emergency use of the product.
+Added: During 2020, the Company's ORAcollect ® ·RNA and OMNIgene ® ·ORAL collection devices were included in EUAs granted by the FDA to certain third parties for use in the detection of SARS-CoV-2, and the Company has separately obtained EUAs for these products.
+Added: In addition, the Company obtained three EUAs for its new InteliSwab® COVID-19 Rapid Test.
+Added: Although there are certain regulatory requirements the FDA has waived for the duration of the EUAs, the Company remains subject to specific conditions of the authorization, including ensuring appropriate labeling as approved by FDA specifically for purposes of the EUA, maintaining records of distribution to authorized laboratories, collecting data on occurrences of any false positives or false negatives, and tracking any adverse events.
+Added: As part of the conditions of authorization, OraSure was required to conduct a clinical study in a pediatric population ages 2-14 and an asymptomatic population in addition to launching an app for consumers to report their test results to public health jurisdictions.
+Added: OraSure has completed the required conditions of authorization with respect to the pediatric claim and launched the InteliSwab® Connect application for reporting test results to public health jurisdictions.
+Added: As a result of the National Institutes of Health study (Performance of Screening for SARS-CoV-2 using Rapid Antigen Tests to Detect Incidence of Symptomatic and Asymptomatic SARS-CoV-2 Infection:
+Added: findings from the Test Us at Home prospective cohort study), the FDA has requested modifications to labeling to include serial testing and has removed the requirement for the Company to conduct a study in an asymptomatic population.
+Added: Labeling has been modified as required for inclusion of serial testing and authorized by FDA.
+Added: As with other FDA-regulated products, issues could emerge during the course of the marketing and use of the Company's products under an EUA that could impact the Company's ability to continue the sale and distribution of these products (for example, compliance or product performance issues).
+Added: The applicable EUAs remain effective only until the HHS declaration is terminated or revoked, and the FDA may also revoke an EUA if it determines the criteria for issuance are no longer met or other circumstances make such revocation appropriate to protect the public health or safety.
+Added: If that were to occur, then in order to market the Company's diagnostic products or collection kits for the purpose of detecting COVID-19 the Company would be required to obtain the necessary regulatory clearances or approvals and be subject to the full and usual regulatory obligations for device manufacturers, including the QMSR under 21 CFR Part 820.
+Added: It is possible that the Company may not be able to obtain those clearances or approvals in a timely manner, or at all, and that one or more of OraSure's competitors may obtain the necessary clearances or approvals for their products before the Company does.
Risks Relating to the Company's Industry, Business and Strategy
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Certain parts of the Company's business may continue to have a high customer concentration and depend disproportionately on a few large customers.
−Removed: To the extent that such a large customers fail to meet their purchase commitments, change their ordering patterns or business strategies, or otherwise reduce their purchases or stop purchasing the Company's products, or if it experiences difficulty in meeting the high demand by these larger customers for its products, the Company's revenues and results of operations could be adversely affected.
+Added: To the extent that such large customers fail to meet their purchase commitments, change their ordering patterns or business strategies, or otherwise reduce their purchases or stop purchasing the Company's products, or if it experiences difficulty in meeting the high demand by these larger customers for its products, the Company's revenues and results of operations could be adversely affected.
The Company is Subject to Risks Related to Government Funding and Customer Ordering.
2 unchanged sentences
Agency for International Development (“USAID”), the Centers for Disease Control and Prevention (“CDC”), and other government programs.
+Added: In 2025, the U.S.
+Added: government implemented funding freezes and delays that have directly affected healthcare and
+Added: life sciences procurement.
Any reduction, delay, or uncertainty in the availability of such funding could adversely affect the purchasing patterns of these customers, impacting our business, financial condition, and results of operations.
−Removed: In recent months, the U.S.
−Removed: government has implemented funding freezes and delays that have directly affected healthcare and life sciences procurement.
−Removed: For example, on January 22, 2025, the Office of Management and Budget (“OMB”) issued a directive halting the disbursement of certain federal funds, pending review of budgetary priorities.
−Removed: Similarly, on February 10, 2025, the U.S.
−Removed: Department of State and USAID announced a 90-day suspension of new foreign assistance obligations, affecting global health initiatives and domestic procurement of essential healthcare supplies.
+Added: Among factors that could adversely affect our business are the impact of actions, such as the U.S.
+Added: government implementing funding freezes and delays;
+Added: other changes in fiscal policies or decreases in available government funding;
+Added: changes in government funding priorities;
+Added: changes in government programs or applicable requirements;
+Added: the impact of the adoption of new laws or regulations or changes to existing laws or regulations on global health initiatives and domestic procurement of essential healthcare supplies;
+Added: changes in government administration and national and international priorities, including developments in the geopolitical environment;
+Added: the termination or reduction in certain funding for research and development, including from BARDA;
+Added: changes in audit policies and procedures of government entities;
+Added: potential delays or changes in the government appropriations process;
+Added: and delays in the payment of our invoices by government payment offices.
Customers that rely on these funding sources may reduce, delay, or cancel orders for our products and services, particularly during periods of political uncertainty.
2 unchanged sentences
Acquisitions or Investments May Not Generate the Expected Benefits and Could Disrupt the Company's Ongoing Business, Distract Its Management, Increase Its Expenses and Adversely Affect Its Business.
−Removed: Since the beginning of 2019, the Company has acquired or made investments in several companies through which it has gained access to new technologies, products and services which are complementary to its existing business and aligned with its long-term business strategy.
+Added: The Company has acquired or made investments in several companies through which it has gained access to new technologies, products and services which are complementary to its existing business and aligned with its long-term business strategy.
For example, in January 2024, the Company announced its investment and entry into wide ranging strategic distribution agreements with KKR Sapphiros L.P.
−Removed: ("Sapphiros"), and in December 2024, the Company acquired Sherlock Biosciences, Inc.
−Removed: ("Sherlock"), expanding the Company's product pipeline with the addition of
−Removed: Sherlock's molecular diagnostics platform.
+Added: ("Sapphiros"), in December 2024, the Company acquired Sherlock, expanding the Company's product pipeline with the addition of Sherlock's molecular diagnostics platform, and in November 2025, the Company acquired BioMedomics, also expanding the Company's product pipeline with the addition of BioMedomics' SickleSCAN™ test for sickle cell disease.
The Company will likely continue to pursue strategic acquisitions or investments as a way to expand its business.
19 unchanged sentences
• An acquisition may result in the loss of the Company's or the acquired company’s key personnel, customers, distributors or suppliers;
−Removed: • An acquisition of a foreign business may involve additional risks, including, but not limited to, foreign currency exposure, liability or restrictions under foreign laws or regulations, and
−Removed: the Company's inability to successfully assimilate differences in foreign business practices or overcome language or cultural barriers and other inherent risks of operating in unfamiliar legal and regulatory environments.
+Added: • An acquisition of a foreign business may involve additional risks, including, but not limited to, foreign currency exposure, liability or restrictions under foreign laws or regulations, and the Company's inability to successfully assimilate differences in foreign business practices or overcome language or cultural barriers and other inherent risks of operating in unfamiliar legal and regulatory environments.
The occurrence of one or more of the above or other factors may prevent the Company from achieving all or a significant part of the benefits expected from an acquisition or investment.
This may adversely affect the Company's financial condition, results of operations and ability to grow its business or otherwise achieve its financial and strategic objectives.
−Removed: We May Fail to Realize the Anticipated Benefits of the Acquisition of Sherlock.
−Removed: The success of the acquisition of Sherlock will depend on, among other things, our ability to combine our business with Sherlock in a manner that allows us to achieve developmental and operational synergies.
−Removed: The integration process could result in the loss of key employees, the disruption of our ongoing business or the ongoing business of Sherlock, or inconsistencies in standards, controls, procedures, or policies, in each case, that could adversely affect our ability to achieve the anticipated benefits of the acquisition.
−Removed: Integration efforts between the two companies will also divert management's attention from our core business and other opportunities that could have been beneficial to our stockholders.
−Removed: An inability to realize the full extent of, or any of, the anticipated benefits of the acquisition, as well as any delays encountered in the integration process, could have an adverse effect on our business and results of operations, which may affect the value of our common stock.
−Removed: If we are unable to achieve these objectives, the anticipated benefits of the acquisition may not be realized fully or at all or may take longer or cost more to realize than expected.
The Company's Revenues Could be Affected by Third-Party Reimbursement Policies and Potential Cost Constraints.
36 unchanged sentences
Our research customers may face increased financial pressure due to this change or any future caps on indirect costs.
−Removed: While, as of the date of this filing, the order has been temporarily stayed, there can be no assurance that it will not take effect or that other adverse actions will not be taken.
+Added: While, as of the date of this filing, a lower court has imposed a permanent injunction preventing the NIH from adopting the policy, which has been subsequently affirmed by a U.S.
+Added: Circuit Court of Appeals, there can be no assurance that further adverse actions will not be taken.
Further, our revenue may be adversely affected if our research customers delay purchases as a result of uncertainties surrounding the approval of government budget proposals, including reduced allocations to government agencies, such as the NIH.
−Removed: The Company has also received government funding for certain research and development projects, including, most recently, through the Rapid Response Partnership Vehicle ("RRVP") for the development of a Marburg Virus Disease ("MVD") rapid antigen test.
+Added: The Company has also received government funding for certain research and development projects, including, most recently, through the Rapid Response Partnership Vehicle ("RRVP") for the development of a Marburg Virus Disease
+Added: ("MVD") rapid antigen test.
The level of available government grants or funding in the U.S.
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Further, the Company's ability to enter into agreements with additional strategic partners depends in part on convincing them that its products can help achieve and accelerate their goals and efforts.
−Removed: The Company's strategy for development and commercialization of products may entail entering into arrangements with distributors or other corporate parties, universities, research laboratories, government agencies, licensees and others.
+Added: The Company's strategy for development and commercialization of products may entail entering into arrangements with distributors or other corporate parties,
+Added: universities, research laboratories, government agencies, licensees and others.
Relying on collaborative relationships could be risky to the Company's business for a number of reasons, including:
89 unchanged sentences
Delays in receipt or failure to receive such approvals, clearances, premarket authorization or certification could have a material adverse effect on the Company's business, financial condition and results of operations.
−Removed: All in vitro diagnostic products that are to be sold in the EU must bear the CE mark indicating conformance with the requirements of the relevant EU in vitro diagnostic medical devices legislation.
+Added: All in vitro diagnostic devices that are to be placed on the market in the EU must bear a CE mark indicating conformity with the applicable requirements of the EU IVDR.
The EU IVDR became applicable on May 26, 2022 and repealed the previous IVDD.
1 unchanged sentence
The Company has obtained the CE mark for several of its existing products under the IVDD.
−Removed: It also intends to apply for CE marks for certain of its future
−Removed: products and is not aware of any material reason why it would be unable to obtain those marks.
+Added: It also intends to apply for CE marks for certain of its future products and is not aware of any material reason why it would be unable to obtain those marks.
However, there can be no assurance that compliance with all provisions of the EU IVDR will be demonstrated and the CE mark will be obtained or maintained for all products that the Company desires to sell in the EU.
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Regulation by the FDA and other federal, state and foreign regulatory agencies impacts many aspects of the Company's operations and the operations of its suppliers and distributors, including manufacturing, labeling, packaging, adverse event reporting, recalls, distribution, storage, advertising, promotion and recordkeeping.
−Removed: The Company is subject to routine inspection by the FDA and other agencies to determine compliance with QSR and FDA regulatory requirements in the United States and other applicable regulations worldwide, including but not limited to ISO standards.
+Added: The Company is subject to routine inspection by the FDA and other agencies to determine compliance with QMSR and FDA regulatory requirements in the United States and other applicable regulations worldwide, including but not limited to ISO standards.
The Company believes that its facilities and procedures are in material compliance with the FDA requirements and ISO standards, but the regulations may be unclear and are subject to change, and the Company cannot be sure that the FDA or other regulators will agree with its compliance with these requirements.
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Failure to comply with the applicable requirements of the FDA can result in, among other things, 483 notices, warning letters, administrative or judicially imposed sanctions such as injunctions, civil penalties, recall or seizure of products, total or partial suspension of production, refusal to grant PMA approval for devices, withdrawal of product registrations, marketing clearances or approvals, or criminal prosecution.
−Removed: The ability of the Company's suppliers to supply critical components or materials and of its distributors to sell its products could also be adversely affected if their operations are determined to be out of compliance.
+Added: The ability of the Company's suppliers to supply critical
+Added: components or materials and of its distributors to sell its products could also be adversely affected if their operations are determined to be out of compliance.
Such actions by the FDA and other regulatory bodies could adversely affect the Company's revenues, costs and results of operations.
1 unchanged sentence
The Company does not promote these products for clinical diagnostic use and they are labeled “For Research Use Only” ("RUO").
−Removed: If the FDA were to disagree with the Company's RUO designation of a product, the Company could be forced to recall and/or stop selling the product until appropriate regulatory clearance or approval has been obtained.
+Added: If the FDA were to disagree with the Company's RUO designation of a product, it could allege that we had misbranded or adulterated our RUO products.
+Added: If the FDA asserts that our RUO products are subject to marketing authorization, or that our RUO products are adulterated or misbranded, our business, financial condition or results of operations could be adversely affected.
In the ordinary course of business, the Company must frequently make subjective judgments with respect to compliance with applicable laws and regulations.
2 unchanged sentences
The Company's Inability to Respond to Changes in Regulatory Requirements Could Adversely Affect Its Business.
−Removed: The Company believes that its products and procedures are in material compliance with all applicable FDA regulations, ISO requirements, and other applicable regulatory requirements, but the regulations regarding the manufacture and sale of
−Removed: its products, the QSR and ISO requirements, and other requirements may be unclear and are subject to change.
+Added: The Company believes that its products and procedures are in material compliance with all applicable FDA regulations, ISO requirements, and other applicable regulatory requirements, but the regulations regarding the manufacture and sale of its products, the QMSR and ISO requirements, and other requirements may be unclear and are subject to change.
Newly promulgated regulations could require changes to the Company's products, necessitate additional clinical trials or procedures, or make it impractical or impossible for it to market its products for certain uses, in certain markets, or at all.
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Because of the number and extent of the laws and regulations affecting the Company's industry, and the number of governmental agencies whose actions could affect its operations, it is impossible to reliably predict the full nature and impact of these requirements.
−Removed: To the extent the costs and procedures associated with complying with these laws and requirements are substantial or it is determined that the Company does not comply, its business and results of operations could be adversely affected.
+Added: To the extent the costs and procedures associated with complying with these laws
+Added: and requirements are substantial or it is determined that the Company does not comply, its business and results of operations could be adversely affected.
+Added: Disruptions at the FDA and Other Government Agencies, Including Staffing Constraints, and Funding Uncertainty, Could Delay or Prevent the Development, Review, Approval, or Commercialization of Our Products and Adversely Affect Our Business.
+Added: Our business depends on the effective functioning of the FDA, the SEC, and other governmental authorities that regulate, review, fund, or otherwise influence the development, approval, manufacturing, and commercialization of our products.
+Added: In recent periods, these agencies have experienced material disruptions, including government shutdowns, workforce reductions, hiring freezes, funding uncertainty, and shifts in policy priorities, and similar conditions may persist or recur.
+Added: These disruptions have resulted in longer and less predictable regulatory review timelines, reduced availability of agency personnel, and delays in inspections, meetings, and other regulatory activities.
+Added: Following a shutdown or funding change, regulatory backlogs and resource constraints may continue for extended periods.
+Added: As a result, our ability to obtain timely regulatory approvals, clearances, or authorizations for new or modified products may be delayed or impaired, which could postpone product launches, increase development costs, require additional studies or data, or prevent products from being commercialized.
+Added: Our regulatory risk is further heightened by the FDA’s increasing workload, evolving oversight priorities, and constraints on its ability to hire and retain experienced personnel.
+Added: Reduced staffing or funding at the FDA or other agencies may limit their capacity to meet performance goals, conduct inspections, or provide timely guidance, which could adversely affect our development timelines and commercial plans.
Failure to Comply With Privacy, Security and Breach Notification Regulations May Increase the Company's Costs.
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The GDPR also confers a private right of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies, and obtain compensation for damages resulting from violations of the GDPR.
−Removed: The GDPR imposes several mandatory requirements on companies that process personal data, including requirements relating to the processing of special category personal data (such as health sensitive data), ensuring a legal basis or condition applies to the processing of personal data, which may include obtaining the consent of the individuals to whom the personal data relates, providing notice to individuals about personal data processing activities, having data processing agreements with third parties who process personal data, notification of personal data breaches to data protection authorities and individuals, and the implementing of safeguards to protect the security and confidentiality of the personal data.
−Removed: The GDPR also imposes strict rules on the transfer of personal data out of the EEA to third countries, including the United States in certain circumstances, unless a derogation exists or a valid GDPR transfer mechanism (for example, the European Commission approved Standard Contractual Clauses, or SCCs, or the EU-US Data Privacy Framework) applies.
−Removed: Any inability to transfer personal data from the EEA to the United States in compliance with data protection laws may impede the Company's ability to conduct trials and may adversely affect its business and financial position.
+Added: The GDPR imposes several mandatory requirements on companies that process personal data, including requirements relating to the processing of special category personal data (such as health sensitive data), ensuring a legal basis or condition applies to the processing of personal data, which may include obtaining the consent of the individuals to whom the personal data relates, providing notice to individuals about personal data processing activities, having data processing agreements with third parties who process personal data, notification of personal data breaches to
+Added: data protection authorities and individuals, and the implementing of safeguards to protect the security and confidentiality of the personal data.
+Added: The GDPR also imposes strict rules on the transfer of personal data out of the EEA/UK to third countries, including the United States in certain circumstances, unless a derogation exists or a valid GDPR transfer mechanism (for example, the European Commission approved Standard Contractual Clauses, or SCCs, or the EU-US Data Privacy Framework) applies.
+Added: Any inability to transfer personal data from the EEA/UK to the United States in compliance with data protection laws may impede the Company's ability to conduct trials and may adversely affect its business and financial position.
+Added: The European Commission has issued a decision recognizing the UK as providing adequate protection under the EU GDPR (the “Adequacy Decision”) ensuring transfers of personal data originating in the EEA to the UK remain unrestricted.
+Added: The UK government has also confirmed personal data transfers from the UK to the EEA remain free flowing.
+Added: Despite Brexit, the UK and EEA data protection regimes remain largely aligned.
+Added: However, there is increasing risk of divergence in application, interpretation and enforcement of these data protection regimes, creating additional regulatory uncertainty.
+Added: For example, the UK Data (Use and Access) Act 2025 (“UK Act”), now in force, further differentiates the UK’s data protection regime from the EEA.
+Added: In December 2025, the European Commission adopted a decision determining that the UK continues to provide a level of data protection that is “essentially equivalent” to the EU standards and extended the validity of the UK adequacy decision for six years, through December 2031.
+Added: While this renewal reduces immediate concerns around the UK’s adequacy for transfers of EU personal data, uncertainty remains regarding how UK data protection laws will evolve in the medium to longer term.
+Added: The lack of clarity on future UK laws and their interaction with EU laws and regulations may affect the Company’s efforts to maintain a harmonized approach to processing European personal data and expose the Company to two parallel regimes where the UK GDPR and EU GDPR both apply with differing interpretation and enforcement approaches.
+Added: This could increase the Company’s legal risk and compliance cost associated with the handling of European personal data, and may require the Company to adapt its privacy and data security compliance programs to account for legal and regulatory divergence between the UK and EEA.
+Added: In addition, EEA Member States have adopted national laws to implement the GDPR that may partially deviate from the GDPR.
+Added: Further, the competent authorities in the EEA Member States may interpret GDPR obligations slightly differently from country to country, such that the Company may be unable to operate in a uniform legal landscape across the EEA.
Complying with the enhanced obligations imposed by the GDPR imposes additional obligations and risk upon the Company's business, and may result in significant costs to its business and require it to amend certain of its business practices.
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Actual or alleged violations of these regulations may be punishable by criminal and/or civil sanctions, and may result in exclusion from participation in federal and state programs.
−Removed: The Company is also subject to the California Consumer Privacy Act (“CCPA”), which creates individual privacy rights and places stringent privacy and security obligations on businesses covered by the law, including obligations to provide detailed disclosures to California consumers about their data collection, use and sharing practices and provide such
−Removed: consumers with ways to opt out of certain uses of sensitive personal information, including health information.
+Added: The Company is also subject to the California Consumer Privacy Act (“CCPA”), which creates individual privacy rights and places stringent privacy and security obligations on businesses covered by the law, including obligations to provide detailed disclosures to California consumers about their data collection, use and sharing practices and provide such consumers with ways to opt out of certain uses of sensitive personal information, including health information.
It also provides for civil penalties for violations and allows for a private right of action for data breaches that is expected to increase data breach litigation.
1 unchanged sentence
Failure to comply with the CCPA or other data processing or security laws, or any changes in these laws, could adversely impact the Company's business and its business plans.
−Removed: Similar laws have been passed and proposed in other states and at the federal level, and if passed, such laws may have potentially conflicting requirements that would make compliance challenging.In addition to these comprehensive consumer privacy laws and proposals, a number of other states have passed or proposed more limited privacy laws that focus on specific privacy issues such as biometric data and the privacy of health and medical information, such as Washington state’s My Health My Data Act, which went into effect in March 2024.
+Added: Similar laws have been passed and proposed in other states and at the federal level, and if passed, such laws may have potentially conflicting requirements that would make compliance challenging.
+Added: In addition to these comprehensive consumer privacy laws and proposals, a number of other states have passed or proposed more limited privacy laws that focus on specific privacy issues such as biometric data and the privacy of health and medical information, such as Washington state’s My Health My Data Act, which went into effect in March 2024.
+Added: The My Health My Data Act imposes new state restrictions and requirements on the processing and sale of consumer health data and creates a private right of action, which further increases the relevant compliance risk.
+Added: Connecticut and Nevada have also passed similar laws regulating consumer health data.
+Added: The effects of state and federal privacy laws are potentially significant and may require us to modify our data processing practices and policies and to incur substantial costs and potential liability in an effort to comply with such legislation.
In addition to privacy and data security laws, we may be contractually subject to industry standards adopted by industry groups and may become subject to such obligations in the future.
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Accordingly, were such a class certified or if we are unable to successfully defend such a suit, then TCPA or other state law damages could have a material adverse effect on our results of operations and financial condition.
+Added: In recent years, there has been increasing public and regulatory scrutiny of the use of cookies by companies in the healthcare space.
+Added: For example, the FTC has brought enforcement actions against online healthcare services and service providers, and there has been an increase in litigation alleging the unauthorized collection and sharing of sensitive health information in violation of federal and state privacy laws.
+Added: While we do not collect HIPAA-regulated PHI via the use of cookies on our websites, and we believe our use of cookies on those websites complies with all applicable laws, we may from time to time receive public or regulatory inquiries about our use of tracking technologies.
+Added: Continued regulation of cookies, changes in the interpretation and enforcement of existing laws and regulations, and increased scrutiny of the use of cookies by healthcare technology companies could restrict our ability to engage in certain activities or require changes to our practices.
+Added: If we are believed or found to have not complied with our obligations under applicable laws, we may also be subject to litigation, substantial financial penalties, injunctive actions and reputational harm.
+Added: All of the above could impact our business, financial condition or results of operations.
+Added: Changes In Tax Laws Or In Their Implementation Or Interpretation May Adversely Affect Us Or Our Investors.
+Added: The rules dealing with the U.S.
+Added: federal, state and local income taxation are constantly under review by persons involved in the legislative process and by the Internal Revenue Service, or IRS, and the U.S.
+Added: Treasury Department.
+Added: Changes to tax laws (which changes may have retroactive application), including with respect to net operating losses and research and development tax credits, could adversely affect us or holders of our common stock.
+Added: In recent years, many changes have been made and changes are likely to continue to occur in the future.
+Added: For example, recent legislation that was signed into law on July 4, 2025 made significant changes to U.S.
+Added: federal tax law.
+Added: It cannot be predicted whether, when, in what form, or with what effective dates, new tax laws may be enacted, or regulations and rulings may be enacted, promulgated or issued under existing or new tax laws, which could result in an increase in our or our stockholders’ tax liability or require changes in the manner in which we operate in order to minimize or mitigate any adverse effects of changes in tax law or in the interpretation thereof.
The Use of New And Evolving Technologies, Such As Artificial Intelligence (“AI”), In Our Offerings May Present Risks And Challenges That Can Impact Our Business Including by Posing Security Risks to Our Confidential Information, Proprietary Information, and Personal Data.
−Removed: We may build and integrate AI into our business practices, and the evolving nature of AI technologies and the surrounding legal and regulatory environment presents risks and uncertainties that could affect our business.
−Removed: The use of AI technology can give rise to intellectual property risks, including compromises to proprietary intellectual property and intellectual property infringement.
−Removed: Additionally, we expect to see increasing government regulation related to artificial intelligence use and ethics, which may also significantly increase the burden and cost of research, development and compliance in this area.
−Removed: For example, in the U.S., a number of states have proposed and passed laws regulating various uses of AI.
−Removed: In Europe, the EU’s Artificial Intelligence Act (“AI Act”) — which entered into force on August 1, 2024 and, with some exceptions, will begin to apply as of August 2, 2026 — imposes significant obligations on providers and deployers of high-risk artificial intelligence systems, and encourages providers and deployers of artificial intelligence systems to account for EU ethical principles in their development and use of these systems.
+Added: We may use and integrate AI into our business practices, including through the adoption of commercially available tools.
+Added: The evolving nature of AI technologies and the surrounding legal and regulatory environment presents risks and uncertainties related to cybersecurity, data privacy, IT, intellectual property, regulatory, legal, operational, competitive, and reputational challenges that could affect our business.
+Added: Specifically, risks related to accuracy, bias, artificial intelligence hallucinations, discrimination, harmful content, misinformation, fraud, scams, targeted attacks (including model poisoning or data poisoning), surveillance, data leakage, inequality, environmental harms, and other harms may flow from our development, use, or deployment of AI technologies.
+Added: The use of AI technology can give rise to intellectual property risks, including disclosures or other compromises to proprietary intellectual property and intellectual property infringement, or by undermining our ability to assert or defend ownership rights in intellectual property created with the assistance of AI tools.
+Added: Over the past year, states have advanced, and in some cases passed, dozens of laws focusing on AI governance and regulation, including on deployment of AI in healthcare settings.
+Added: At the federal level, the Trump Administration has endorsed a federal moratorium on the enforcement of state AI laws, including through a December 11, 2025, executive order on “Ensuring a National Policy Framework for Artificial Intelligence.” So far, these efforts have not been successful at curtailing state action on AI regulation, contributing to a complicated legislative patchwork, which may be litigated in state and federal courts.
+Added: In Europe, the EU begin implementing the Artificial Intelligence Act (“AI Act”) on August 1, 2024, with a significant part of the law scheduled to come into effect in August 2026.
+Added: As currently enacted, the AI Act, which may be amended as part of the EU’s Digital Omnibus, which entered into force on August 1, 2024 and, with some exceptions, will begin to apply as of August 2, 2026, imposes significant obligations on providers and deployers of high-risk artificial intelligence systems, and encourages providers and deployers of artificial intelligence systems to account for EU ethical principles in their development and use of these systems.
If we develop or deploy AI systems that are governed by these laws and regulations, we may be required to adopt higher standards of data quality, transparency, and human oversight, and adhere to specific and potentially burdensome and costly ethical, accountability, and administrative requirements.
−Removed: Even in the absence of dedicate AI laws and regulations, we may be subject to novel legal and business risks relating to our adoption of these new technologies.
−Removed: Our vendors may in turn incorporate AI tools into their own offerings, and the providers of these AI tools may not meet existing or rapidly evolving regulatory or industry standards, including with
−Removed: respect to privacy and data security.
+Added: Even in the absence of dedicated AI laws and regulations, we may be subject to novel legal and business risks relating to our adoption of these new technologies.
+Added: In addition, the use of generative AI models in our internal or third-party systems may create new attack surfaces or methods for adversaries, which could impact us and our vendors.
+Added: Our vendors may in turn incorporate AI tools into their own offerings, and the providers of these AI tools may not meet existing or rapidly evolving regulatory or industry standards, including with respect to privacy and data security.
Further, bad actors around the world use increasingly sophisticated methods, including the use of AI, to engage in illegal activities involving the theft and misuse of personal information, confidential information, and intellectual property.
1 unchanged sentence
FDA Regulation of Laboratory-Developed Tests and Genetic Testing Could Affect Demand For the Company's Products.
−Removed: The FDA has regulatory responsibility over instruments, test kits, reagents and other devices used to perform diagnostic testing by clinical laboratories.
In the past, the FDA has taken the position that it has regulatory authority over laboratory-developed tests ("LDTs"), but has exercised enforcement discretion in not regulating most LDTs performed by high complexity CLIA-certified laboratories.
11 unchanged sentences
On April 29, 2024, the FDA published a final rule on LDTs, in which FDA outlines its plan to end enforcement discretion for many LDTs in five stages over a four-year period.
−Removed: • In Phase 1 (effective May 6, 2025), clinical laboratories would be required to comply with medical device reporting, correction/removal reporting, and certain quality systems complaint handling requirements.
−Removed: • In Phase 2 (effective May 6, 2026), clinical laboratories would be required to comply with all other device requirements (e.g., establishment registration and device listing, labeling, investigational use requirements), except for remaining quality systems requirements and premarket review requirements.
−Removed: • In Phase 3 (effective May 6, 2027), clinical laboratories would be required to comply with all remaining quality systems requirements.
−Removed: • In Phase 4 (effective November 6, 2027), clinical laboratories would be required to comply with premarket submission requirements for high-risk tests (i.e., tests subject to FDA's premarket approval (PMA) requirement).
−Removed: • In Phase 5 (effective May 6, 2028), clinical laboratories would be required to comply with premarket submission requirements for moderate- and low- risk tests (i.e., tests subject to de novo classification or the 510(k) requirement).
−Removed: On May 29, 2024, the American Clinical Laboratory Association filed a lawsuit challenging the FDA's authority to regulate LDTs as medical devices under the FDCA.
−Removed: Subsequently, on August 19, 2024, the Association for Molecular Pathology filed a lawsuit similarly challenging FDA's final rule on LDTs.
−Removed: The outcomes of these lawsuits is uncertain at this time.
+Added: However, in March 2025, a federal district court judge issued a decision that vacated the FDA’s final rule on the grounds that the FDA did not have authority under the FDCA to promulgate it because LDTs do not fall within the statutory definition of “device.” This district court ruling was not appealed, and the FDA’s final rule will no longer be implemented or enforced by the FDA.
+Added: Stakeholders continue to press for a comprehensive legislative solution to create a harmonized paradigm for oversight of LDTs by both the FDA and CMS, although it is unclear whether any future legislative efforts towards such a goal would be successful.
+Added: The outcome and ultimate impact on our business of any future changes to the federal government’s regulation of LDTs via legislative enactments is difficult to predict.
The Company's subsidiary, DNAG, sells its DNA collection systems to certain laboratories and other customers for use with LDTs.
2 unchanged sentences
In recent years, the Department of Justice indicted a number of telemedicine companies and cancer genetic testing laboratories for allegedly submitting fraudulent insurance claims to Medicare.
−Removed: A number of these companies were customers of DNAG.
+Added: In the past, a number of these companies were purchasing DNAG products.
As a result of these activities, the FDA has issued letters to genetic testing laboratories indicating that it plans to increase oversight of this market which has caused some of these companies to stop providing testing options or to change how they are reporting the information provided by the testing.
−Removed: The activities have negatively affected this market and there is a risk that these enforcement actions will continue to negatively affect this market by forcing
−Removed: laboratories to either stop offering such services or restricting the use of such services.
+Added: The activities have negatively affected this market and, should these enforcement actions continue despite the district court's ruling on FDA's final rule on LDT's, there is a risk that these enforcement actions will continue to negatively affect this market by forcing laboratories to either stop offering such services or restricting the use of such services.
Such a reduction in testing could result in decreased sales of the Company's DNA collection devices.
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The Company Has Experienced Losses in the Past and May Not Be Able to Again Achieve and Maintain Profitable Operations .
−Removed: The Company has experienced annual net losses during the five years prior to 2015, between 2020 through 2022 and again recorded net losses for the year ended December 31, 2024 .
+Added: The Company has experienced annual net losses during the five years prior to 2015, between 2020 through 2022 and again recorded net losses for the years ended December 31, 2024 and 2025 .
In addition, as of December 31, 2025, the Company had an accumulated deficit of $172.2 million.
18 unchanged sentences
Recent Volatility In Capital Markets and Lower Market Prices For the Company's Securities May Affect Its Ability to Access New Capital Through Sales of Shares of Its Common Stock or Issuance Of Indebtedness, Which May Materially Harm Its Liquidity, Limit Its Ability to Grow Its Business, Pursue Acquisitions or Improve Its Operating Infrastructure and Restrict Its Ability to Compete in Its Markets .
−Removed: The Company's operations consume substantial amounts of cash, and it intends to continue to make significant investments to support its business growth, respond to business challenges or opportunities, develop new solutions, retain or expand its current levels of personnel, improve its existing solutions, enhance its operating infrastructure, and potentially acquire complementary businesses and technologies.
+Added: The Company's operations consume substantial amounts of cash, and it intends to continue to make significant investments to support its business growth, respond to business challenges or opportunities, develop new solutions, retain or expand its current levels of personnel, improve its existing solutions, enhance its operating infrastructure, and potentially acquire
+Added: complementary businesses and technologies.
The Company's future capital requirements may be significantly different from its current estimates and will depend on many factors, including the need to:
18 unchanged sentences
Increasing Geopolitical and Economic Risk and Tariffs Could Negatively Affect Our Ability to Maintain Sales at Existing Levels
−Removed: The imposition of tariffs, non-tariff barriers, and other import and export restrictions have contributed to increased global economic uncertainty.
−Removed: The rise of economic nationalism could make it more difficult for us to attract new customers, retain existing customers, continue to produce and source in an optimal manner, maintain our supply chain, or maintain sales at existing levels, both in the United States and in other countries.
+Added: Geopolitical and macroeconomic developments, including the imposition or expansion of tariffs, non-tariff barriers and trade restrictions, or other protectionist measures have contributed to increased uncertainty and volatility in global markets.
+Added: These actions could increase the cost of materials, components, or finished goods, make it more difficult for us to attract new customers, retain existing customers, continue to produce and source in an optimal manner, maintain our supply chain, or maintain sales at existing levels, both in the United States and in other countries.
+Added: Trade‑related measures have in the past, and may in the future change with limited notice and could be accompanied by retaliatory actions by other countries.
Geopolitical and economic risks, together with trade protectionism have increased over the past few years in many regions of the world, including in the United States.
1 unchanged sentence
Growing tensions, protectionist trade policies, and tariffs may also lead to a fragmentation of the global economy, a general reduction of international trade in goods and services, and a reduction in the integration of financial markets, any of which could materially and adversely affect our business results, cash flows, financial condition, or prospects.
+Added: Changes in political leadership, statutory frameworks, or regulatory policy in the United States and abroad may further affect the interpretation, implementation, or enforcement of laws and regulations applicable to our business.
+Added: If regulatory disruptions, staffing constraints, funding limitations, or trade actions continue or intensify, our business, financial condition, results of operations, and prospects could be materially and adversely affected.
An Impairment of Goodwill and Intangible Assets Could Reduce the Company's Earnings .
15 unchanged sentences
These exchange rate fluctuations could negatively impact international sales of the Company's products, as could changes in the general economic conditions in those markets.
−Removed: In addition, the revenues and expenses of the Company's subsidiary, DNAG, are recorded in Canadian dollars and the revenues and expenses of its subsidiary Novosanis are recorded in Euros.
+Added: In addition, the revenues and expenses of the Company's subsidiary, DNAG, are recorded in Canadian dollar.
Revenues and expenses denominated in foreign currencies are translated into U.S.
dollars for purposes of reporting consolidated financial results.
−Removed: The Company's expectation is that the businesses of its foreign subsidiaries will continue to grow and its exposure to foreign currency exchange rates may be more significant than in past years.
−Removed: Exchange rate fluctuations may affect the revenues and expenses of the Company's foreign subsidiaries and the translation of those financial results into U.S.
+Added: The Company's expectation is that the businesses of its foreign subsidiary will continue to grow and its exposure to foreign currency exchange rates may be more significant than in past years.
+Added: Exchange rate fluctuations may affect the revenues and expenses of the Company's foreign subsidiary and the translation of those financial results into U.S.
Favorable movement in exchange rates have benefited the Company in prior periods.
8 unchanged sentences
The following factors, among others, could have a significant impact on the market for the Company's Common Stock:
−Removed: • The performance of the Company's business, including its efforts to increase sales of OraQuick ® HIV, HCV and sample management solutions and its OraQuick ® In-Home HIV test and HIV Self-Test;
+Added: • The performance of the Company's business, including its efforts to increase sales of OraQuick ® HIV, HCV and sample management solutions and its OraQuick ® HIV Self-Test;
• Future announcements concerning the Company and its products or services, including with respect to significant acquisitions, strategic collaborations and joint ventures;
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• Additions or departures of key personnel;
−Removed: • General market and economic conditions;
+Added: • General market and economic conditions, including those related to inflation, interest rates, tariffs and foreign currency exchange rates;
• Terrorist attacks, civil unrest, war and national disasters, including pandemics.
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Any adverse determination in this type of litigation could also subject the Company to significant liabilities.
+Added: Share Repurchases Could Increase the Volatility of the Trading Price of Our Common Stock and Diminish Our Cash Reserves, and We Cannot Guarantee That Our Stock Repurchase Program Will Enhance Long-Term Stockholder Value.
+Added: On March 21, 2025, our Board authorized the repurchase of up to $40.0 million in shares of our common stock pursuant to a stock repurchase program (the “Repurchase Program”).
+Added: The Repurchase Program does not obligate us to repurchase any minimum dollar amount or number of shares, and can be modified, terminated or suspended at any time.
+Added: Repurchases of shares of our common stock could affect the trading price of our common stock and increase volatility of such securities.
+Added: Similarly, the future announcement of the modification, suspension or termination of the Repurchase Program, or our decision not to utilize the full authorized repurchase amount under the Repurchase Program, could result in a decrease in the trading price of our common stock.
+Added: In addition, the Repurchase Program could have the impact of reducing our cash reserves, which may impact our ability to finance our growth, fund working capital, strategic acquisitions or business opportunities, and other general corporate purposes and execute our strategic plan.
+Added: Although the Repurchase Program is
+Added: intended to enhance long-term stockholder value, there can be no assurance that it will do so because the trading price of our common stock may decline below the levels at which we repurchased our shares and short-term stock price fluctuations could reduce the effectiveness of the Repurchase Program.
Future Sales of the Company's Common Stock by Existing Stockholders, Executive Officers or Directors Could Depress the Market Price of Its Common Stock and Make It More Difficult for the Company to Sell Stock in the Future.
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General Risk Factors
+Added: Our Business Could be Negatively Affected as a Result of Actions of Activist Stockholders.
+Added: While we value open dialogue and input from our stockholders, activist stockholders could take actions that could adversely affect our business.
+Added: Specifically, responding to common actions of an activist stockholder, such as requests for potential nominations of candidates for election to our Board of Directors, requests to pursue a strategic combination, or other transaction or other special requests, could disrupt our operations, be costly and time-consuming, or divert the attention of our management and employees.
+Added: In addition, perceived uncertainties as to our future direction in relation to the actions of an activist stockholder may result in the loss of potential business opportunities or the perception that we are unstable as a company, which may make it more difficult to attract and retain qualified employees.
+Added: Our ability to continue to commit to our mission, guiding principles, and culture may also be questioned, which could impact our ability to attract and retain business.
+Added: Actions of an activist stockholder may also cause fluctuations in our stock price based on speculative market perceptions or other factors that do not necessarily reflect the underlying fundamentals and prospects of our business.
The Company May Face Product Liability Claims for Injuries Resulting From the Use of Its Products.
−Removed: The Company may be held liable if any of its products, or any product which is made with the use or incorporation of any of its technologies, causes injury of any type or is found otherwise unsuitable during product testing, manufacturing, marketing, sale or usage.
+Added: The Company may be held liable if any of its products, or any product which is made with the use or incorporation of any of its technologies, causes injury of any type or is found otherwise unsuitable during product testing, manufacturing,
+Added: marketing, sale or usage.
There is no assurance that the Company would be successful in defending any product liability lawsuits brought against it.
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• Incurrence of damages payable to plaintiffs.
−Removed: The Company is selling the InteliSwab ® COVID-19 Rapid Test and the OraQuick ® In-Home HIV test in the United States OTC market, and it offers HIV Self-Tests to consumers internationally.
+Added: The Company is selling the InteliSwab ® COVID-19 Rapid Test and the OraQuick ® HIV Self-Test in the United States OTC market, and it offers HIV Self-Tests to consumers internationally.
The Company believes the sale of products for use by consumers increases its potential exposure to product liability and other claims.
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In addition, poor performance by one or more of the Company's products and publicity surrounding such performance could have an adverse effect on the Company's reputation, its continuing ability to sell products and the prevailing market price of its Common Stock.
−Removed: The Company's Ability to Sell Products Could be Adversely Affected by Competition From New and Existing Products and Services.
−Removed: The markets the Company serves are highly competitive and rapidly changing and it expects competition to intensify as technological advances are made and become more widely known, and as new products and services reach the market.
−Removed: Many of the Company's principal competitors have considerably greater financial, technical and marketing resources than it does.
−Removed: As new products and services enter the market, the Company's products and services may become obsolete or a competitor’s products and services may be more effective or attractive or more effectively marketed and sold than the Company's.
−Removed: In addition, there can be no assurance that the Company's competitors will not succeed in obtaining regulatory approval for new products and services that would render the Company's technologies, products and services obsolete or otherwise commercially unattractive, or introduce or commercialize such products and services before the Company can do so.
−Removed: If the Company fails to convince its customers of the advantages and economic value of its products and services or otherwise maintain and enhance its competitive position, its customers may decide to use products and services developed by competitors which could result in a loss of revenues.
−Removed: These developments could have a material adverse effect on the Company's business, financial condition and results of operations.
−Removed: The Company also faces competition from products that are sold at a lower price.
−Removed: Where this occurs, customers may choose to buy lower cost products from third parties or the Company may be forced to sell its products at a lower price, both of which could result in a loss of revenues or a lower gross margin contribution from the sale of its products.
−Removed: The Company may also be required to increase its marketing efforts in order to compete effectively, which would increase its costs.
Failure to Achieve the Company's Financial and Strategic Objectives Could Have a Material Adverse Impact on Its Business Prospects.
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Similarly, if adequate financial, personnel, equipment or other resources are not available, the Company may be required to delay or scale back its business.
−Removed: The Company's operations will be adversely affected if its total revenue and gross profits do not correspondingly increase or if its technology, product, service, clinical and market development
−Removed: efforts are unsuccessful or delayed.
+Added: The Company's operations will be adversely affected if its total revenue and gross profits do not correspondingly increase or if its technology, product, service, clinical and market development efforts are unsuccessful or delayed.
Furthermore, the Company's failure to successfully introduce new or enhanced products and services and develop new markets could have a material adverse effect on its business and prospects.
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The Company is required to comply with the requirements of the Sarbanes-Oxley Act of 2002, or SOX, which requires that it maintain effective internal control over financial reporting and disclosure controls and procedures.
−Removed: In particular, the Company must perform system and process evaluation, document its controls and perform testing of its key controls over financial reporting to allow management and its independent public accounting firm to report on the effectiveness of its internal control over financial reporting, as required by Section 404 of SOX.
+Added: particular, the Company must perform system and process evaluation, document its controls and perform testing of its key controls over financial reporting to allow management and its independent public accounting firm to report on the effectiveness of its internal control over financial reporting, as required by Section 404 of SOX.
The Company's testing, or the subsequent testing by its independent public accounting firm, may reveal deficiencies in its internal control over financial reporting that are deemed to be material weaknesses.
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Cyber-attacks and other cybersecurity incidents such as ransomware, phishing, and social engineering attacks could result in unauthorized access to the Company's computer systems or its third-party IT service providers' systems and, if successful, misappropriate personal, sensitive, or confidential information.
−Removed: As previously disclosed, the Company has in the past and may in the future experience cybersecurity incidents.
+Added: As previously disclosed, the Company has, like others in its industry, in the past and may in the future experience cybersecurity incidents.
If successful, these attacks could lead to service interruptions, extortion, theft of confidential, personal or proprietary information, the compromise of data integrity or unauthorized information disclosure.
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The Company has outsourced significant elements of its IT infrastructure and, as a result, it manages relationships with third-party providers who may or could have access to the Company's sensitive and confidential information.
−Removed: The Company relies on technology developed, supplied and/or maintained by third-parties that may make the Company vulnerable to “supply chain” style cyber-attacks.
+Added: The Company relies on technology developed, supplied and/or maintained by third-parties that may make the Company
+Added: vulnerable to “supply chain” style cyber-attacks.
Further, technology and security vulnerabilities of acquisitions, business partners or third-party providers may not be identified during due diligence or soon enough to mitigate exploitation.
−Removed: The size and complexity of the Company's IT and information security systems, and those of its third-party providers (and the large amounts of confidential information that is present on them), make such systems potentially vulnerable to service interruptions or to security incidents from inadvertent or intentional actions by, but not limited to, Company employees, service providers, business partners, customers or malicious attackers.
+Added: The size and complexity of the Company's IT and information security systems, and those of its third-party providers (and the amount of confidential information that is present on them), make such systems potentially vulnerable to service interruptions or to security incidents from inadvertent or intentional actions by, but not limited to, Company employees, service providers, business partners, customers or malicious attackers.
In addition, a contractor or other third party with whom the Company does business may attempt to circumvent its security measures or obtain such information, and may purposefully or inadvertently cause an incident involving sensitive information.
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Although this can vary from quarter to quarter, many customers make purchase decisions late in a quarter due to budgetary or financial requirements.
−Removed: In addition, certain governmental customers must fully spend budgeted funds by the end of their fiscal year or risk losing these funds, which can contribute to fluctuations in the Company's sales from year-to-year.
+Added: In addition, certain governmental customers must fully spend budgeted funds by the end of their fiscal year or risk losing these funds, which can contribute to fluctuations in the
+Added: Company's sales from year-to-year.
This can make it difficult to accurately forecast whether the Company will achieve its quarterly sales forecasts and can cause variability in its operating results.
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Actual events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions, transactional counterparties or other companies in the financial services industry or the financial services industry generally, or concerns or rumors about any events of these kinds or other similar risks, have in the past and may in the future lead to market-wide liquidity problems.
−Removed: For example, in early 2023, several financial institutions closed and were taken in receivership by the Federal Deposit Insurance Corporation.
−Removed: Since then, additional financial institutions have experienced similar failures and have been placed into receivership.
−Removed: It is possible that other banks will face similar difficulty in the future.
Although the Company does not maintain any deposit accounts, credit agreements or letters of credit with any financial institution currently in receivership, it is unable to predict the extent or nature of the impacts of these evolving circumstances at this time.
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While it is not possible at this time to predict the extent of the impact that the failure of these financial institutions or the high market volatility and instability of the banking sector could have on economic activity and the Company's business in particular, the failure of other banks and financial institutions and the measures taken by governments, businesses and other organizations in response to these events could adversely impact the Company's business, financial condition and results of operations.
−Removed: Economic Volatility and Disruption Resulting from the COVID-19 Pandemic and any Future Pandemic and Health Crises Could Adversely Affect the Company’s Business, Financial Performance, Results of Operations, Cash Flow and Financial Condition or Those of Its Customers and Suppliers.
−Removed: Global and U.S.
−Removed: markets and economies have experienced extreme volatility and disruption following the COVID-19 pandemic.
−Removed: Volatile economic conditions may occur again or continue in the future.
−Removed: Impacts of the COVID-19 pandemic that the Company has or may experience in the future include, but are not limited to:
−Removed: • a slowdown or stoppage in the supply chain of the raw materials and components used to manufacture its products;
−Removed: • interruptions or delays in domestic and/or international shipment of its products to its distributors and customers;
−Removed: • interruptions in normal operations of certain end-use customers that could result in reductions in demand for its products;
−Removed: • disruptions to the Company’s operations, including a shutdown of its facilities or product lines;
−Removed: restrictions on its operations and sales, marketing and distribution efforts;
−Removed: and interruptions to its research and development, manufacturing, clinical/regulatory and other important business activities;
−Removed: • shutdown or interruption of the Company’s manufacturing facilities due to contamination and costs incurred to clean and disinfect a facility following contamination;
−Removed: • inefficiencies and increased costs in the Company’s production and shipping processes due to premium pay for manufacturing and certain other employees as well as social distancing and personal protective equipment requirements;
−Removed: • limitations on employee resources and availability, including due to sickness, government restrictions, the desire of employees to avoid contact with large groups of people or mass transit disruptions;
−Removed: • a fluctuation in foreign currency exchange rates or interest rates could result from market uncertainties;
−Removed: • an increase in exposure to credit losses for customers adversely affected by the COVID-19 pandemic and any future health crises;
−Removed: • an increase in regulatory restrictions or continued market volatility could hinder the Company’s ability to execute strategic business activities, including acquisitions.
−Removed: These conditions could adversely affect the Company’s financial performance and condition or those of its customers and suppliers.
−Removed: These circumstances could also adversely affect the Company’s access to liquidity needed to conduct or expand its business or conduct future acquisitions or make other discretionary investments.
−Removed: Many of the Company’s customers rely on public funding provided by federal, state and local governments, and this funding has been and may continue to be reduced or deferred as a result of economic conditions or other factors.
−Removed: These circumstances may adversely impact the Company’s customers and suppliers, which, in turn, could adversely affect their ability to purchase and/or distribute the Company’s products or supply it with necessary equipment, raw materials or components.
−Removed: Any or all of these effects would have an adverse effect on the Company’s operations, business, financial condition and results of operations.
Terrorist Attacks, Natural Disasters, Public Health Crises, Political Unrest or Other Catastrophic Events Outside of the Company's Control May Adversely Affect Its Business.
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These events disrupted the Company's normal operation and the operations of its customers and suppliers.
−Removed: In addition, the impacts of political unrest, including as a result geopolitical tension, such as a deterioration in the relationship between the United States and China, escalation of tensions between China and Taiwan, or escalation in conflict between Russia and Ukraine or the Israel-Hamas war, including any resulting sanctions, export controls or other restrictive actions that may be imposed by the United States and/or other countries against governmental or other entities in, for example, Russia, also could lead to disruption, instability and volatility in the global markets, which may have an adverse impact on the Company's business or ability to access the capital markets.
+Added: In addition, the impacts of political unrest, including as a result geopolitical tension, such as a deterioration in the relationship between the United States and China, escalation of tensions between China and Taiwan, or escalation in conflict between Russia and Ukraine or the conflict in Iran, including any resulting sanctions, export controls or other restrictive actions that may be imposed by the United States and/or other countries against governmental or other entities in, for example, Russia, also could lead to disruption, instability and volatility in the global markets, which may have an adverse impact on the Company's business or ability to access the capital markets.
As a result of the ongoing military conflict between Russia and Ukraine, the United States and other countries have imposed significant sanctions on Russia and could impose even wider sanctions.
Such sanctions could damage or disrupt international commerce and the global economy.
−Removed: The Company cannot predict the broader or longer-term consequences of the conflict in Ukraine or Israel, or of the sanctions imposed to date, which could include embargoes, regional instability, geopolitical shifts, exchange rate fluctuations, financial market disruptions and economic recession.
−Removed: Further, the conflict in Ukraine or Israel could exacerbate supply chain challenges, lead to an increase in cyberattacks, affect the global price and availability of key commodities, reduce the Company’s sales and earnings or otherwise have an adverse effect on its business and results of operations.
+Added: The Company cannot predict the broader or longer-term consequences of the conflict in Ukraine or Iran, or of the sanctions imposed to date, which could include embargoes, regional instability, geopolitical shifts, exchange rate fluctuations, financial market disruptions and economic recession.
+Added: Further, the conflict in Ukraine or Iran could exacerbate supply chain challenges, lead to an increase in cyberattacks, affect the global price and availability of key commodities, reduce the Company’s sales and earnings or otherwise have an adverse effect on its business and results of operations.
Various types of disasters, including earthquakes, fires, floods, riots, acts of terrorism and pandemics, may also affect the Company's manufacturing facilities and computer systems, and increase its cybersecurity risks.
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Moreover, the Company may incur incremental costs following an unforeseen event which could adversely affect its results of operation.
−Removed: The Increasing Prevalence of AI-based Software Presents New Risks and Could Adversely Affect Our Business and Reputation.
−Removed: AI-based software and software making use of AI functionality, which the Company uses in certain parts of its business, is increasingly being used in the healthcare industry, such as for research, marketing, and commercialization, and we expect to use technology that uses AI in the future.
−Removed: As with many developing technologies, AI-based software presents risks and challenges.
−Removed: For example, algorithms may be flawed;
−Removed: data sets may be insufficient, of poor quality or contain biased information;
−Removed: and inappropriate or controversial data practices could impair results.
−Removed: If the analyses that AI-based software assist in producing are deficient or inaccurate, we could be subjected to competitive harm, potential legal liability and brand or reputational harm.
−Removed: Use of AI-based software may also lead to cybersecurity risks or the release of confidential proprietary information, including personal data, which may impact our ability to realize the benefit of our intellectual property or violate our internal policies, data protection laws or contractual requirements.
−Removed: The use of AI-based software may also result in unauthorized access of personal data or the intellectual property of third parties.
−Removed: Since the use of AI is
−Removed: subject to new or evolving laws and regulations, compliance may impose operational costs and limit our ability to use AI-based software, and failure to comply may result in potential government actions, litigation, fines, penalties or adverse publicity.
Future Sales of Shares of the Company's Common Stock Could Adversely Affect the Trading Price of Its Common Stock and Its Ability to Raise Funds in New Equity Offerings.
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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.