What changed in this filing

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Item 1. Business

2026-03-09 compared with 2025-03-07 · 115 added, 135 removed, 442 unchanged (36% of the section changed)

OTI transforms health through actionable insight by powering the shift that connects people to healthcare wherever they are.

OTI transforms health through actionable insight and decentralizes diagnostics to connect people to healthcare wherever they are.

Our products and services reside under one reporting hierarchy, with commercial and innovation teams, which are part of a single business unit covering multiple product lines.

Our business is principally comprised of the development, manufacture, marketing, sale and distribution of (i) diagnostics products, and (ii) sample management solutions.

In January 2024, the Company completed an equity investment in KKR Sapphiros L.P.

("Sapphiros"), leading its Series B financing and entering into a wide-ranging strategic distribution relationship with Sapphiros, which secures exclusive distribution rights to certain products in Sapphiros' development pipeline, including self-collected blood test and diagnostic tests.

Sapphiros is a privately held consumer diagnostics portfolio company based in Boston.

In December 2024, the Company acquired Sherlock Biosciences, Inc.

and its subsidiaries ("Sherlock").

Sherlock is a global health company focused on next generation diagnostics.

Sherlock's molecular diagnostics platform aims to provide rapid results with strong sensitivity and specificity in a disposable format.

Sherlock's first test for Chlamydia Trachomatis (CT) and Neisseria Gonorrhoeae (NG) is currently in Phase 3 clinical studies and is expected to be submitted to the FDA for approval by the end of 2025.

Subject to regulatory approvals, this test is expected to expand the Company's portfolio for rapid diagnostics for sexually transmitted infections.

In November 2025, the Company acquired BioMedomics, Inc.

("BioMedomics").

BioMedomics' SickleSCAN ® test is the world's first rapid point-of-care test for sickle cell disease.

The SickleSCAN ® test is currently sold in markets outside the U.S.

Products and Services

The Company's business consists of the development, manufacture, marketing, sale and distribution of simple, easy to use diagnostic products and specimen collection devices using its proprietary technologies, as well as other diagnostic products including immunoassays and other in vitro diagnostic tests.

Our diagnostic products include tests for diseases including HIV, Hepatitis C, Syphilis and COVID-19 that are performed on a rapid basis at the point of care.

The Company's business consists of the development, manufacture, marketing, sale and distribution of simple, easy to use diagnostic products and specimen collection devices using its proprietary technologies, as well as other diagnostic products, including immunoassays and other in vitro diagnostic tests that are used on other specimen types.

Our diagnostic products include tests for diseases including HIV, Hepatitis C virus (“HCV”), Syphilis, Sickle Cell and COVID-19 that are performed on a rapid basis at the point of care.

These products are sold in the United States and internationally to various clinical laboratories, hospitals, clinics, community-based organizations, and other public health organizations, distributors, government agencies, physicians’ offices, and commercial and industrial entities.

The Company's HIV, HCV and COVID-19 products are also sold in a consumer-friendly format in the over-the-counter (“OTC”) market in the U.S.

and, in the case of the HIV and HCV products, as a self-test to individuals in a number of other countries, including, for the HIV products, as an oral swab in-home test for HIV-1 and HIV-2 in Europe.

The Company's HIV and COVID-19 products are also sold in a consumer-friendly format in the over-the-counter (“OTC”) market in the U.S.

In December 2025, the Company submitted a premarket notification (“510(k)”) the FDA for clearance of its rapid molecular self-test for Chlamydia trachomatis and Neisseria gonorrhoeae (“CT/NG”), which is currently under review.

The Company's business also includes sample management solutions and services that are used by clinical laboratories, direct-to-consumer laboratories, researchers, pharmaceutical companies, and animal health service and product providers.

The revenues from sample management solutions are derived from product sales to commercial customers and sales into the academic and research markets.

Customers span the disease risk management, diagnostics, pharmaceutical, biotech, companion animal and environmental market segments.

Customers span the disease risk management, diagnostics, pharmaceutical, biotech, companion animal market segments.

The Company has also developed collection devices for the emerging microbiome market, which focuses on studying microbiomes and their effect on human and animal health.

The Company also has a urine collection device which allows for the volumetric collection of first void urine.

This product is in its early stages, and initial sales are occurring primarily through distributors and collaborations in the liquid biopsy and sexually transmitted disease markets.

In 2020, the Company expanded its market focus by selling existing collection products for use with COVID-19 tests.

Beginning in 2022 and continuing through 2024, demand for COVID-19 PCR testing declined significantly, which was primarily driven by the availability of antigen tests, the reduction in the number of COVID-19 cases, and the wider availability of vaccines that negatively impacted the sales of the collection products.

Initial sales of this product for research use only are occurring primarily through distributors and collaborations in the liquid biopsy and sexually transmitted disease markets.

In December 2025, the Company also submitted a 510(k) to the FDA for clearance of its Colli-Pee ® at-home urine collection device for sexually transmitted infections, which is currently under review.

The following is a summary of the Company's principal products for the infectious disease and risk management markets as well as its sample management products:

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The OraQuick ADVANCE® test has received premarket approval (“PMA”) from the FDA for the detection of antibodies to both HIV-1 and HIV-2 in oral fluid, finger-stick whole blood, venous whole blood and plasma.

The OraQuick® test has received World Health

Organization ("WHO") pre-qualification and registration in other countries for the detection of HIV-1 and HIV-2 antibodies in oral fluid, whole blood (fingerstick and venous), serum and plasma.

The OraQuick ® test has received World Health Organization ("WHO") pre-qualification and registration in other countries for the detection of HIV-1 and HIV-2 antibodies in oral fluid, whole blood (fingerstick and venous), serum and plasma.

In November 2022, the US FDA reclassified HIV serological diagnostic tests from Class III to Class II with special controls reducing the regulatory burden for these device types.

The device uses a porous flat pad to collect an oral fluid specimen.

After collection, the pad is inserted into a vial containing a pre-measured amount of developer solution and allowed to develop.

When blood-based specimens are to be tested, a loop collection device is used to collect a drop of the specimen and mix it in the developer solution, after which the collection pad is inserted into the solution and the test is allowed to develop.

When blood-based

specimens are to be tested, a loop collection device is used to collect a drop of the specimen and mix it in the developer solution, after which the collection pad is inserted into the solution and the test is allowed to develop.

The specimen and developer solution then flow through the testing device where test results are observable between 20 and 40 minutes.

The OraQuick ® device is a screening test and requires a confirmation test where an initial positive result is obtained.

This test is available for use by laboratories located in the United States certified under CLIA, to perform moderately complex tests.

This test is available for use by laboratories located in the United States certified under a Clinical Laboratory Improvement Amendments of 1988 (“CLIA”), to perform moderately complex tests.

The Company has also received a CLIA waiver for use of the test with oral fluid and finger-stick and venous whole blood.

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The Company has also received WHO pre-qualification for its export-only version of this product.

OraQuick ® In-Home HIV Test

The OraQuick ® In-Home HIV test is an OTC oral-fluid only version of the Company's OraQuick ADVANCE ® HIV 1/2 Antibody Test.

The Company received PMA approval to sell this test in the U.S.

The In-Home test is performed in the same manner as the OraQuick ADVANCE ® test, except that it has product labeling and instructions designed for consumers.

In addition, the Company has established toll-free, 365-day per year customer telephone support to provide additional information and referral services for consumers that use this product.

On January 7, 2025, the Company announced that the FDA had approved a premarket approval application supplement for a labeling change to include individuals 14 years of age and older.

The previous approval was available for individuals 17 years of age and older.

OraQuick ® HIV Self-Test

The OraQuick ® HIV Self-Test is an in-vitro diagnostic home-use test for HIV (HIV-1 and HIV-2) in oral fluid, and is sold for use by individuals.

OraQuick ® HIV Self-Test is sold for use by individuals in certain foreign countries, including under the CE mark in certain European countries, to meet the needs of those markets.

The OraQuick ® HIV Self-Test is an OTC oral-fluid only version of the Company's OraQuick ADVANCE ® HIV 1/2 Antibody Test.

The Company received PMA approval to sell this test in the U.S.

OTC market for individuals 14 years of age and older.

The test is performed in the same manner as the OraQuick ADVANCE ® test, except that it has product labeling and instructions designed for consumers.

The OraQuick In-Home HIV Self-Test was rebranded to OraQuick HIV Self-Test as part of a PMA supplement in 2024.

In addition, the Company has established toll-free customer telephone support to provide additional information and referral services for consumers that use this product.

OraQuick ® HIV Self-Test (International)

The OraQuick ® HIV Self-Test (International) is an in-vitro diagnostic home-use test for HIV (HIV-1 and HIV-2) in oral fluid, and is sold for use by individuals.

OraQuick ® HIV Self-Test (International) is sold for use by individuals in certain foreign countries, including under the CE mark in certain European countries, to meet the needs of those markets.

This product has received WHO pre-qualification and is eligible for procurement by purchasing entities entitled to access funding and other resources from the Global Fund, PEPFAR and other agencies.

In February 2026, the Company announced that the OraQuick ® HIV Self-Test (International) received a license from Health Canada for use in Canada and is Canada’s first oral HIV self-test.

OraQuick ® HCV Rapid Antibody Test and Self-Test

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The Company has received FDA PMA approval and CLIA waiver for use of the test in detecting HCV antibodies in venous whole blood and finger-stick whole blood specimens, making it the first and only rapid HCV test approved by the FDA for use in the United States.

The OraQuick ® HCV test has received a CE mark for use with oral fluid, venous whole blood, finger-stick whole blood, plasma and serum and is sold in Europe.

In November 2021, the US FDA reclassified Hepatitis C virus (HCV) antibody tests for the qualitative detection of HCV from Class III to Class II with special controls reducing the regulatory burden for these device types.

OraQuick ® HCV test has received a CE mark for use with oral fluid, venous whole blood, finger-stick whole blood, plasma and serum and is sold in Europe.

This CE-marked product is also registered and sold in other foreign countries and has received WHO pre-qualification.

Additionally, the OraQuick ® HCV Self-Test is an over the counter self-test that operates in substantially the same way as the OraQuick ® HCV rapid antibody test.

Additionally, the OraQuick ® HCV Self-Test is an OTC self-test, available in certain markets outside the U.S., that operates in substantially the same way as the OraQuick ® HCV rapid antibody test.

The OraQuick ® HCV self-test received WHO pre-qualification in 2024 and is the first hepatitis C self-test to earn this designation.

Diagnostics Direct Syphilis Health Check ™

In February 2024, the Company entered into a strategic agreement with Diagnostics Direct to distribute its Syphilis Health Check ™ rapid diagnostic test.

Pursuant to a strategic agreement with Diagnostics Direct, the Company distributes the Syphilis Health Check ™ rapid diagnostic test.

Syphilis Health Check ™ is the first CLIA-waived treponemal test.

The test, which uses fingerstick whole blood and delivers point of care results in 10 minutes, offers the ability to test in non-traditional

environments, such as outreach programs and mobile testing clinics.

The test, which uses fingerstick whole blood and delivers point of care results in 10 minutes, offers the ability to test in non-traditional environments, such as

outreach programs and mobile testing clinics.

Syphilis Health Check ™ is approved for use with people aged 13 years and older.

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The uses for this test are limited to individuals that meet certain criteria indicating they may be infected with the Ebola virus, so the test is not available for general screening of individuals that do not meet this criteria.

In September 2022, the Company entered into an agreement with the Biomedical Advanced Research and Development Authority ("BARDA"), pursuant to which BARDA will provide up to $8.6 million in funding to the Company to develop a 2nd generation Ebola test on the OraQuick ® testing platform with the objective of developing increased sensitivity, utilizing sustainable raw materials and increasing shelf life, with new chemistry and higher degrees of automation in the test’s manufacturing process.

In September 2022, the Company entered into an agreement with the Biomedical Advanced Research and Development Authority (“BARDA”), pursuant to which BARDA will provide up to $8.6 million in funding to the Company to develop an updated Ebola test on the OraQuick ® testing platform with the objective of developing increased sensitivity, utilizing sustainable raw materials and increasing shelf life, with new chemistry and higher degrees of automation in the test’s manufacturing process.

In September 2023, the agreement was modified to add an additional $6.9 million in funding to be used to obtain the appropriate regulatory approvals for the product.

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The InteliSwab ® COVID-19 Rapid Test Rx is the version of InteliSwab ® that has received EUA from the FDA for prescription home use with individuals aged 2 years or older who are suspected of COVID-19 infection by their healthcare provider within the first seven days of symptom onset.

Intercept ® Drug Testing System

A collection device that is substantially similar to the OraSure ® collection device is sold under the name Intercept ® , and is used to collect oral mucosal transudate for oral fluid drug testing.

The Company has received FDA 510(k) clearance to use the Intercept ® collection device with laboratory-based EIAs to test for drugs-of-abuse commonly identified by the National Institute for Drug Abuse (“NIDA”) as the NIDA-5 (i.e., tetrahydrocannabinol (“THC” or marijuana), cocaine, opiates, amphetamines/methamphetamines and phencyclidine (“PCP”)), and for barbiturates, methadone and benzodiazepines.

Each of these EIAs is also FDA 510(k) cleared for use with the Intercept ® device.

The Intercept ® device and oral fluid assays are sold in the U.S.

primarily through laboratory distributors.

The Company has also developed a next-generation collection device, which it is marketing under the trade name “Intercept i2 ® he ”.

This device offers several important advantages over the original Intercept ® device, including a sample adequacy indicator that provides a visual prompt when the appropriate volume of oral fluid has been collected, the ability to collect a larger sample required by current laboratory testing protocols and a more optimized chemistry that results in improved recovery of the targeted drug analytes.

The Intercept i2 ® he device is sold as a forensic use only device within the criminal justice and drug treatment markets along with a panel of fully-automated high-throughput oral fluid drug assays that the Company distributes under an agreement with Thermo Fisher Scientific.

In November 2024, the Company announced that it intended to exit the substance abuse testing business.

Though the Company will continue to fulfill final orders for certain of its Intercept ® Drug Testing System products through the first half of 2025, it substantially ceased the production and sale of substance abuse testing products as of the end of 2024.

Immunoassay Tests and Reagents

The Company develops and sell immunoassay tests in formats, known as MICRO-PLATE and AUTO-LYTE ® , to meet the specific needs of its customers.

The Company also sell fully-automated high-throughput oral fluid drug assays developed under its agreement with Thermo Fisher Scientific.

The Company's MICRO-PLATE tests can be performed on commonly used instruments and can detect drugs in oral fluid, urine, serum and sweat specimens.

MICRO-PLATE tests are also used as part of the Intercept ® product line to detect drugs-of-abuse in oral fluid specimens and the Company is selling a panel of high-throughput assays supplied by Thermo Fisher Scientific to the U.S.

forensic market under the agreement described above.

AUTO-LYTE ® tests are sold in the form of bottles of liquid reagents, are run on commercially available laboratory-based automated analytical instruments, and are typically used in high volume, automated, commercial reference insurance laboratories to detect certain drugs or chemicals in urine.

In November 2024, the Company announced that it intended to exit the substance abuse testing business.

Though the Company will continue to fulfill final orders for certain of its immunoassay products through the first half of 2025, it substantially ceased the production and sale of substance abuse testing products as of the end of 2024.

SickleSCAN ® Test

The Company’s SickleSCAN ® test is a rapid, multiplexed, qualitative point-of care immunoassay for the diagnosis of Sickle cell disorders, and is made up of three indicators, which detect the presence of hemoglobins A, S, and C, allowing the user to rapidly distinguish between normal, carrier, and sickle cell disease samples.

The SickleSCAN ® test is the world’s first rapid point-of-care test for the diagnosis of sickle cell disease.

The SickleSCAN ® test is currently sold outside the U.S.

through the Company’s international sales channels.

Genomic Products

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• Compatibility with fully automated laboratory testing systems.

Colli-Pee ® Urine Collection Device

The Company also sells the Colli-Pee ® collection device for the volumetric collection of first void urine samples.

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The Colli-Pee ® collection device is registered as a class I urine collection device without a claim for preservative.

The Colli-Pee ® collection device with preservative solution does not have FDA clearance and is labeled “For Research Use Only” in the U.S.

The Colli-Pee ® collection device with preservative solution known as NucleoPrecision™ chemistry, does not have FDA clearance and is labeled “For Research Use Only” in the U.S.

In December 2025, the Company also submitted a 510(k) to the FDA for clearance of its Colli-Pee ® at-home urine collection device, with NucleoPrecision™ chemistry, for sexually transmitted infections, which is currently under review.

HEMAcollect™ • PROTEIN Blood Collection Device

In July, 2025, the Company announced the launch of the HEMAcollect™ • PROTEIN blood collection device, an evacuated blood collection tube (“BCT”) designed to preserve and stabilize plasma proteins in whole blood for up to 7 days.

The BCT uses our proprietary stabilizing liquid, known as ProteoPrecision™ chemistry, and preserves plasma proteins, facilitating storage and transport of blood samples at ambient temperatures.

It is anticipated that its use for sample collection will deliver operational efficiencies to proteomic researchers and support the generation of high-quality data.

The HEMAcollect™ • PROTEIN BCT is currently available for research use only.

Microbiome Products

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The Company's OMNIgene ® •GUT Dx collection device received de novo authorization from the FDA for collection of human fecal samples and the stabilization of DNA from the bacterial community for subsequent assessment of the microbiome profile by an assay validated for use with OMNIgene ® ·GUT Dx device.

Laboratory and Data Analytical Services

During the third quarter of 2024, the Company exited its microbiome laboratory testing and data analytical services, with the Company continuing to close out limited and modest final service orders.

These services focused on accelerating microbiome discovery for customers in the pharmaceutical, agriculture, and research communities.

OMNIgene ® •XTRACT

The Company's OMNIgene ® •XTRACT kit enables the rapid and efficient extraction of high-quality DNA from fecal samples that are validated for gut microbiome samples.

Other Products

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This generic version is a Class I medical device for the detection of cocaine and cotinine in oral fluid specimens for risk assessment testing.

® Saliva Alcohol Test

The Company's Q.E.D.® saliva alcohol test is a point-of-care test device that is a cost-effective alternative to breath or blood alcohol testing.

The test is a quantitative, saliva-based method for the detection of ethanol, has been cleared for sale by the FDA and has received a CLIA waiver.

Department of Transportation (“DOT”) has also approved the test.

Substance Abuse Products

• Intercept® Drug Testing System — Oral fluid collection devices and related laboratory-based and automated assays for drugs-of-abuse testing, including the Intercept® and Intercept i2®he platforms.

• Immunoassay Tests and Reagents — MICRO-PLATE and AUTO-LYTE immunoassay products and related high-throughput assays used in forensic and clinical laboratory drug testing.

• Q.E.D.® Saliva Alcohol Test — A point-of-care, FDA-cleared and CLIA-waived saliva-based test for quantitative detection of ethanol.

In November 2024, the Company announced that it intended to exit the substance abuse testing business.

Though the Company will continue to fulfill final orders for certain of its Q.E.D.® saliva alcohol test through the first half of 2025, it substantially ceased the production and sale of substance abuse testing products as of the end of 2024.

Though the Company continued to fulfill final orders for certain of the foregoing products through the first half of 2025, it has ceased the production and sale of substance abuse testing products.

The Company's substance abuse testing products were marketed to laboratories serving the workplace testing, forensic toxicology, criminal justice and drug rehabilitation markets in the U.S.

and certain international markets.

Products Under Development

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These programs typically focus on products related rapid tests for various diseases.

The Company is developing a 2 nd generation Ebola test on the OraQuick® testing platform with funds obtained under its contract with BARDA.

The Company is developing an updated Ebola test on the OraQuick® testing platform with funds obtained under its contract with BARDA.

The Company is developing a single-use lateral flow immunoassay intended for the qualitative detection of antigens from viruses within the Marburg virus genus.

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75A50123D00005.

Through its Sherlock subsidiary, the Company is developing a molecular self-test for Chlamydia Trachomatis (CT) and Neisseria Gonorrhoeae (NG), which is currently in clinical studies.

Through its Sherlock subsidiary, the Company is developing a rapid molecular self-test for CT/NG.

The Company acquired this program in connection with its acquisition of Sherlock.

Through its Sherlock subsidiary, the Company is also developing of a Covid/Flu molecular test, funded in part with Federal funds obtained from the HHS Administration for Strategic Preparedness and Response (ASPR) under contract number:

In December 2025, the Company submitted a 510(k) to the FDA for clearance of the CT/NG test, which is currently under review.

Through its Sherlock subsidiary, the Company is also developing a Covid/Flu molecular test, funded in part with Federal funds obtained from the HHS Administration for Strategic Preparedness and Response (ASPR) under contract number:

75A50124C00055.

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Sample Management Solutions

In order to intersect evolving customer needs within the academic and commercial markets, the Company's sample management solutions business product development pipeline is focused on extending offerings across different sample types and analytes within both the genomics and microbiome areas.

Genomic customers are demonstrating an increasing demand for collection and stabilization of cell-free nucleic acids, exosomes, DNA and RNA.

Genomic and proteomic customers are demonstrating an increasing demand for collection and stabilization of cell-free nucleic acids, exosomes, proteins, DNA and RNA, while infectious disease customers have expressed growing interest in at-home urine collection for STI testing.

In December 2025, the Company submitted a 510(k) to the FDA for clearance of its Colli-Pee ® at-home urine collection device for sexually transmitted infections, which is currently under review.

On the microbiome front, the Company continues to focus research and development work on collecting and stabilizing microbial DNA, RNA and metabolites from multiple sample types including gut, skin, vagina and saliva.

The Company is working to develop a blood proteomics product, which, if approved, the Company expects will be used in emerging applications, like liquid biopsy, oncology and neurology, and in connection with chronic illnesses like Alzheimer's and diabetes.

Sales and Marketing

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The Company markets the OraQuick ADVANCE ® HIV-1/2 antibody test directly to customers in the public health market for HIV testing.

This market consists of a broad range of clinics and laboratories and includes states, counties, and other

governmental agencies, family planning clinics, colleges and universities, correctional facilities and the military.

This market consists of a broad range of clinics and laboratories and includes states, counties, and other governmental agencies, family planning clinics, colleges and universities, correctional facilities and the military.

There are also a number of organizations in the public health market, such as AIDS service organizations and various community-based organizations, that are set up primarily for the purpose of encouraging and enabling HIV testing.

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The OTC InteliSwab ® test is also sold directly and through distributors into a broad range of business-to-business (B2B) markets including employer testing, colleges and universities, local, state and federal governmental agencies and the U.S.

The Company sells its OraQuick ® In-Home HIV test in the U.S.

The Company sells its OraQuick ® HIV Self-Test in the U.S.

retail or consumer market as well as to the same markets as the OraQuick ADVANCE ® test for use in public health-oriented programs.

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WHO prequalification enables governmental organizations implementing self-test pilots and programs to access international funding to purchase the Company's test.

Substance Abuse Testing

On November 6, 2024, the Company announced that it intended to exit the substance abuse testing business.

Though the Company will continue to fulfill final orders for certain of its substance abuse testing products, it substantially ceased the production and sale of such products as of the end of 2024.

The Company's substance abuse testing products are marketed to laboratories serving the workplace testing, forensic toxicology, criminal justice and drug rehabilitation markets in the U.S.

and certain international markets.

Sample Management Solutions and Molecular Services

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The Colli-Pee ® collection device with preservative solution does not have FDA clearance and is labeled “For Research Use Only” in the U.S.

In December 2025, the Company submitted a 510(k) to the FDA for clearance of its Colli-Pee ® at home urine collection device for sexually transmitted infections.

Significant Products and Customers

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OraQuick ® HIV

InteliSwab® 45,136 257,493 233,666

$ 49,802 $ 60,804 $ 60,823

620 45,136 257,493

Genomics 31,546 44,861 47,005

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Supply and Manufacturing

The Company manufactures its InteliSwab ® COVID-19 Rapid Test, OraQuick ADVANCE ® Rapid HIV test, OraQuick ® In-Home HIV test, OraQuick ® HCV test, OraQuick ® Ebola test, OraSure ® , Intercept ® and Intercept i2 ® he collection devices, AUTO-LYTE ® and MICRO-PLATE assays and Q.E.D.

The Company manufactures its InteliSwab ® COVID-19 Rapid Test, OraQuick ADVANCE ® Rapid HIV test, OraQuick ® HIV Self-Test, OraQuick ® HCV test, OraQuick ® Ebola test, OraSure ® , Intercept ® and Intercept i2 ® he collection devices, AUTO-LYTE ® and MICRO-PLATE assays and Q.E.D.

® saliva alcohol test in its Bethlehem, Pennsylvania facilities.

With the exception of its substance abuse testing products, the Company expects to continue to manufacture these products at this location for the foreseeable future.

The Company expects to continue to manufacture these products at this location for the foreseeable future.

The Company has contracted with a third party in Thailand for the assembly of the OraQuick ® Rapid HIV test and the OraQuick ® HIV Self-Test in order to supply certain international markets.

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Throughout 2025, the Company made progress on consolidating its manufacturing footprint by using the Opus Way facility for a more significant portion of its manufacturing and distribution needs, including re-shoring of capacity to the United States.

The Company's MICRO-PLATE and AUTO-LYTE ® assays require the production of highly specific and sensitive antibodies corresponding to the analyte of interest.

Substantially all the Company's antibody raw materials are provided by

contract suppliers.

The Company believes that it has adequate reserves of antibody supplies and that it has access to sufficient raw materials for these products.

DNAG has three long-term contract manufacturing relationships to supply virtually all of its products, including the Oragene ® product line.

The Company manufactures the majority of DNAG's products, including the Oragene ® and Colli-Pee ® product lines at its Bethlehem, Pennsylvania facilities.

DNAG maintains two long-term relationships to manufacture additional volumes of certain products.

Many of the raw materials and components used in these products are also purchased from third parties, some of which are purchased from a single source supplier.

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All DNAG products are produced in Canada and the United States.

The Company's Colli-Pee ® device is currently being manufactured in Canada by its existing contract manufacturers with components supplied by third party vendors.

Human Capital Resources

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As of December 31, 2025, the Company had 500 full-time employees, which compares to 501 employees as of December 31, 2024.

The decrease in employees during 2024 was the result of the need to reduce manufacturing capacity for the Company's InteliSwab ® COVID-19 Rapid Test, transition away from the microbiome molecular sequencing services business and close its Belgian operations.

In addition, the Company exited its risk assessment business.

The Company's employees are not currently represented by a U.S.

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The future market for diagnostic products is expected to be characterized by greater cost consciousness, the development of new technologies, tighter reimbursement policies and consolidation.

The purchasers of diagnostic products are expected to place increased emphasis on lowering costs, reducing inventory levels, obtaining better performing products, automation, service and volume discounts.

The purchasers of diagnostic products are expected to

place increased emphasis on lowering costs, reducing inventory levels, obtaining better performing products, automation, service and volume discounts.

The Company expects competition to intensify as technological advances are made and become more widely known, and as new products reach the market.

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The Company's OraQuick ® rapid HCV test competes against laboratory-based blood tests in the U.S., as there currently are no other rapid HCV testing products approved by the FDA.

The Company's OraQuick ® In-Home HIV oral fluid test is the only rapid HIV test approved by the FDA for sale in the U.S.

The Company's OraQuick ® HIV Self-Test oral fluid test is the only rapid HIV test approved by the FDA for sale in the U.S.

Outside the U.S., the Company's rapid HIV and HCV tests compete against other rapid and laboratory-based tests, which require blood as a sample.

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The Company's Oragene ® and ORAcollect ® products are also facing increasing competition from similarly designed collection systems which have entered the market.

OMNIgene ® • GUT is being sold in the emerging microbiome market and competes with a variety of non-standard in-house solutions developed by various researchers, including simply freezing the sample after collection.

The Company's OMNIgene ® • GUT device is being sold in the emerging microbiome market and competes with a variety of non-standard in-house solutions developed by various researchers, including simply freezing the sample after collection.

The microbiome market is expected to require standardization in the methods used for collection and stabilization in order to derive more accurate and repeatable results.

To date, the Company is one of the few vendors to offer a solution that fully meets these requirements.

The Company's genomic, microbiome and metatranscriptomics laboratory service offerings primarily compete against a number of commercial reference laboratories, specialty laboratories and hospital laboratories in the U.S.

Patents and Proprietary Information

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The Company has patents throughout its product lines.

Its patent portfolio includes pending applications and issued patents in diagnostics and testing, sampling tools and sample preservatives.

Its patent portfolio includes pending applications, issued patents, and licensed patents in diagnostics and testing, sampling tools and sample preservatives.

The Company's portfolio protects its innovative sampling tools, sample preservatives, and diagnostics that provide access to accurate, essential information that advances global health and well-being.

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One related design patent is issued in the U.S.

and will expire in November 2038, and other related design patent applications are pending in the U.S., Canada, and Europe.

and will expire in August 2040, and other related design patent applications are pending in the U.S., Canada, and Europe.

The Company has additional pending applications directed to new direct sample collection pads for its InteliSwab ® COVID-19 Rapid Test.

These applications entered their national phase in countries throughout the world in October 2023, and patents issuing from these applications will expire in December 2042.

Two related design patents issued in 2022 in the

These applications entered their national phase in countries throughout the world in October 2023, and patents issuing from these applications will expire in November 2044.

Two related design patents issued in 2024 in the U.S.

and corresponding design applications were registered in Canada, China, India, and Europe.

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The Company has registered design patents for a collection funnel and corresponding plunger device in Europe, Canada China, India, and the U.S.

The Company has two international families of patent applications filed in the United States and in numerous countries worldwide.

The Company has an international family of patent applications filed in the United States and in numerous countries worldwide.

These applications are directed to novel nucleoside reverse transcriptase inhibitor-specific antibodies for use in assays to detect the presence of nucleoside reverse transcriptase inhibitor drug derivatives, including tenofovir, in fluid samples.

Patents issuing from these applications will expire in October 2038 and December 2040.

The Company holds, through its subsidiary, DNAG, nineteen granted United States patents and numerous foreign patents issued for compositions, methods and apparatuses for the collection, stabilization, transportation, and storage of nucleic acids (DNA and RNA) from oral fluid and other bodily fluids and tissues.

Certain patents expired in June 2023, and others will expire through November 2040.

Patents issuing from these applications will expire between October 2038 and May 2041.

The Company holds, through its subsidiary, DNAG, seventeen issued United States patents and numerous foreign patents issued for compositions, methods and apparatuses for the collection, stabilization, transportation, and storage of nucleic acids (DNA and RNA) from oral fluid and other bodily fluids and tissues.

Certain patents expired in April 2026, and others will expire through November 2040.

The Company holds one granted United States patent and numerous foreign patents covering a medical device for capturing a predetermined volume of first void urine.

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The Company owns rights to trademarks and service marks that it believes are necessary to conduct its business as currently operated.

In the United States, the Company owns a number of trademarks, including the OraSure ® , Intercept ® , Intercept i2 ® he, Intercept i2 he ® , OraQuick ® , OraQuick ADVANCE ® , ORASURE QUICKFLU ® , SUREQUICK ® , Q.E.D.

® , InteliSwab ® , Oragene ® , DNA Genotek ® , OMNImet ® , ORAcollect ® , OMNIgene ® , Diversigen ® , CoreBiome ® , Boostershot ® , MetaGene ® , Benchmark ® , Novosanis ® , Colli-Pee ® , UCM ® , UAS™, THINK OUTSIDE THE CUP ® , AUTO-LYTE ® , prepIT ® , and HEMAgene ® trademarks.

The Company also licenses the SHERLOCK™ mark from The Broad Institute, Inc.

In the United States, the Company owns a number of trademarks, including the OraSure ® , OTI™, OraQuick ® , OraQuick ADVANCE ® , ORASURE QUICKFLU ® , SUREQUICK ® , InteliSwab ® , SMART SCIENCE MADE SIMPLE ® , Oragene ® , DNA Genotek ® , OMNImet ® , ORAcollect ® , OMNIgene ® , Diversigen ® , CoreBiome ® , Boostershot ® , MetaGene ® , Benchmark ® , Novosanis ® , Colli-Pee ® , UCM ® , UAS™, prepIT ® , NucleoPrecision™, ProteoPrecision™, HEMAcollect™, and HEMAgene ® trademarks..

The Company also licenses the SHERLOCK™ mark from The Broad

Institute, Inc.

The Company also owns many of these marks and others in several foreign countries and it is pursuing registration of several other trademarks.

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To be substantially equivalent, an applicant must show that when compared to a predicate, the new device has the same intended use and same technology, or if different technology, that the new device is as safe and effective as the predicate and does not raise different questions of safety and effectiveness.

In all cases, data from some form of performance testing is required and in some cases, the submission must include data from human clinical studies.

In all cases, data from some form of performance testing is required and in some cases, the submission must

include data from human clinical studies.

An applicant must submit a 510(k) notification at least 90 days before commercial distribution of the product commences.

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If the FDA approves the PMA, it may place restrictions on the device.

If the FDA’s evaluation of the PMA or the manufacturing facility is not favorable, the FDA may deny approval of the PMA application or issue a “not approvable”

If the FDA’s evaluation of the PMA or the manufacturing facility is not favorable, the FDA may deny approval of the PMA application or issue a “not approvable” letter.

The FDA may also require additional clinical trials, which can delay the PMA approval process by several years or prevent a PMA approval from being obtained.

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A clinical trial may be required in support of a 510(k) submission and generally is required for a De Novo request or PMA application.

These trials generally require an approved application for an Investigational Device Exemption (“IDE”) and compliance with other IDE requirements, unless the proposed study is deemed to be exempt from the IDE requirements.

These trials generally require an approved application for an Investigational Device Exemption (“IDE”) and

compliance with other IDE requirements, unless the proposed study is deemed to be exempt from the IDE requirements.

An IDE application must be supported by appropriate data, such as laboratory testing results, protocols for the proposed investigation, and other information demonstrating that the device is appropriate for use with humans in a clinical study.

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The FDA does not currently regulate products used for these purposes, although other state and federal regulatory requirements may apply.

Most devices distributed in the United States must comply with the FDA’s Quality System Regulations (“QSRs”), including current good manufacturing practices.

Most devices distributed in the United States must comply with the FDA’s Quality Management System Regulations (“QMSRs”), including current good manufacturing practices.

These regulations govern the entire life cycle of a medical device, including design, manufacture, testing, release, packaging, distribution, documentation and purchasing as well as complaint handling, corrective and preventative actions, and internal auditing.

In complying with the QSRs, manufacturers must continue to expend time, money and effort in the area of production, quality, and post-market surveillance to ensure full compliance.

In complying with the QMSRs, manufacturers must continue to expend time, money and effort in the area of production, quality, and post-market surveillance to ensure full compliance.

Companies that market devices are also subject to other post-market and general requirements, including product listing and establishment licenses, which help facilitate FDA inspections and other regulatory action, post-market surveillance requests, restrictions imposed on marketed products, promotional standards and requirements for recordkeeping and reporting of certain adverse reactions and device malfunctions.

Device reporting regulations require that manufacturers report if their device may have caused or contributed to a death or serious injury, or has malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction of the device or a similar device were to recur.

The FDA regularly inspects companies to determine compliance with the QSRs and other post-market requirements.

The FDA regularly inspects companies to determine compliance with the QMSRs and other post-market requirements.

Failure to comply with statutory requirements and the FDA’s regulations can result in an FDA Form 483 (which is issued by the FDA at the conclusion of an inspection when an investigator has observed any conditions that may constitute violations), public warning letters, monetary penalties against a company or its officers and employees, suspension or withdrawal of regulatory approvals, operating restrictions, total or partial suspension of production, injunctions, product recalls, product detentions, refusal to provide export certificates, seizure of products and criminal prosecution.

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 International Organization for Standardization (“ISO”), ISO 13485:2016.

The rule will become effective on February 2, 2026.

Until then, manufacturers are required to comply with the QSR.

The Company believes that its facilities and procedures are in material compliance with the FDA’s QSR requirements, the European Union's Quality Management Systems requirements, ISO 13485:2016, and other post-market requirements, but the regulations are subject to change or may be unclear, and the Company cannot be sure that FDA investigators will agree with the Company's compliance with the FDA’s post-market requirements.

The Company believes that its facilities and procedures are in material compliance with the requirements of the FDA’s QMSR, the European Union's Quality Management Systems requirements, ISO 13485:2016, and other post-market requirements, but the regulations are subject to change or may be unclear, and the Company cannot be sure that FDA investigators will agree with the Company's compliance with the FDA’s post-market requirements.

CLIA prohibits any facility that conducts laboratory testing on specimens derived from humans from providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of, the health of human beings, unless there is in effect for such facility a certificate issued by the U.S.

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The Company has obtained a waiver of the CLIA requirements for its OraQuick ADVANCE ® rapid HIV-1/2 antibody test, its OraQuick ® HCV rapid antibody test and its Q.E.D.

® alcohol saliva test and may seek similar waivers for certain other products.

saliva test and may seek similar waivers for certain other products.

The InteliSwab ® COVID-19 Rapid Test Pro is authorized for use in patient care settings operating under CLIA Certificate, Certificate of Compliance and Certificate of Accreditation.

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In addition, under the federal Lanham Act and similar state laws, competitors and others can initiate litigation relating to advertising claims.

If the FDA determines that the Company's promotional materials or training constitute promotion of an uncleared or unapproved use, it could request that the Company modify its training or promotional materials or subject the Company to regulatory or enforcement actions, including the issuance of an untitled letter, a notice

of violation, a warning letter, injunction, seizure, civil fine or criminal penalties.

Federal Trade Commission enforcement actions often result in consent decrees that constrain future actions.

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To obtain this certificate from the FDA, the device manufacturer must apply to the FDA.

The FDA certifies that the product has been granted clearance or approval in the United States and that the manufacturing facilities were in compliance with QSR regulations at the time of the last FDA inspection.

If the FDA determines that the Company's facilities or procedures do not comply with the QSR regulations, it may refuse to provide such certificates until the Company resolves the issues to the FDA’s satisfaction.

The FDA certifies that the product has been granted clearance or approval in the United States and that the manufacturing facilities were in compliance with QMSR regulations at the time of the last FDA inspection.

If the FDA determines that the Company's facilities or procedures do not comply with the QMSR regulations, it may refuse to provide such certificates until the Company resolves the issues to the FDA’s satisfaction.

Failure to obtain a CFG could inhibit the Company's ability to export its products to countries that require such certificates.

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The EU Medical Devices Regulation (EU) 2017/745 (the “EU MDR”) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (the “EU IVDR”), which repealed and replaced the Medical Devices Directive 93/42/EEC (“MDD”) and the In Vitro Diagnostic Medical Devices Directive 98/79/EC (“IVDD”) respectively, govern the regulation of medical devices and in vitro diagnostic devices in the European Union (“EU”).

The EU MDR and EU IVDR impose stricter pre-market and post-market requirements for the marketing and sale of medical devices and in vitro diagnostic medical devices than the previous Directives, including in the area of clinical evaluation requirements, quality systems and post-market surveillance.

The EU MDR and EU IVDR impose

stricter pre-market and post-market requirements for the marketing and sale of medical devices and in vitro diagnostic medical devices than the previous Directives, including in the area of clinical evaluation requirements, quality systems and post-market surveillance.

The EU IVDR became fully applicable on May 26, 2022.

There is a transitional period (which was extended in July 2024) during which products that have a declaration of conformity issued under the IVDD prior to May 26, 2022 may continue to be placed on the EU market for a certain period before requiring certification under the EU IVDR (subject to compliance with certain requirements under the EU IVDR, including in respect of post-market surveillance);

however, class A non-sterile products do not benefit from such transitional provisions and have been required to be EU IVDR compliant since May 26, 2022.

The transition deadline for other classes of devices ranges between December 21, 2027 and December 31, 2029, provided certain transitional activities are performed by earlier deadlines (e.g.

the manufacturer must sign a formal written agreement with a notified boy for assessment under the EU IVDR).

however, Class A non-sterile devices do not benefit from such transitional provisions and have been required to fully comply with the EU IVDR compliant since May 26, 2022.

The transition deadline for other classes of devices ranges from December 31, 2027 to December 31, 2029, provided certain transitional activities are performed by earlier deadlines (e.g.

the manufacturer must sign a formal written agreement with a notified body for assessment under the EU IVDR).

In the EU, products that fall under the scope of the MDR and the EU IVDR may not be placed on the EU market without a valid CE mark.

Approval of a regulatory authority is not required to obtain CE certification, but, depending on the class of product, conformity assessment by a notified body may be required.

Approval of a national regulatory authority is not required to obtain a CE mark;

however, depending on the class of product, conformity assessment by a notified body may be required.

Notified bodies are accredited and supervised by national regulatory authorities to conduct conformity assessment procedures of medical devices or other products.

The conformity assessment procedure for medical devices and in vitro diagnostic devices is to assess whether the device is compliant with the general safety and performance requirements set forth in the EU MDR or EU IVDR (as applicable), and includes an examination of the product’s technical dossier and the manufacturer’s quality system.

ISO certification of the quality system in accordance with the relevant standard for medical devices or in vitro diagnostic devices creates a rebuttable presumption that the product satisfies the applicable requirements of the EU MDR or EU IVDR (as applicable)

with respect to the quality management system.

Compliance with these general safety and performance requirements allows the Company to complete the applicable conformity assessment procedure, involving a notified body where necessary, and to affix the CE mark to its products, without which they may not be placed on the market in the EU.

The Company also notes that from January 1, 2021, the United Kingdom (“UK”) has introduced a UK-specific route to market for medical devices.

Compliance with these requirements may add further complexities to the Company's international strategy.

Compliance with these UK requirements may add further complexities to the Company's international strategy.

The Company must also comply with certain registration and licensing requirements as dictated by Health Canada, prior to commencing sales in Canada.

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A violation of the Federal Anti-Kickback Statute is considered a violation of the FCA.

Some suits filed under the FCA, known as “qui tam” actions, can be brought by a “whistleblower” or “relator” on behalf of the government, and such individuals may share in any amounts paid by the entity to the government in fines or settlement.

Some suits filed under the FCA, known as “qui tam” actions, can be brought by a “whistleblower” or “relator” on behalf of the

government, and such individuals may share in any amounts paid by the entity to the government in fines or settlement.

Manufacturers can be held liable under false claims laws, even if they do not submit.

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These laws and regulations are wide ranging and subject to changing interpretation and application.

In recent years, there has been greater scrutiny of marketing practices in the

medical device industry which has resulted in several government investigations by various government authorities and the introduction and/or passage of federal and state legislation regulating interactions between medical device manufacturers and healthcare professionals and providers and requiring the disclosure by medical device manufacturers of payments to certain healthcare providers.

In recent years, there has been greater scrutiny of marketing practices in the medical device industry which has resulted in several government investigations by various government authorities and the introduction and/or passage of federal and state legislation regulating interactions between medical device manufacturers and healthcare professionals and providers and requiring the disclosure by medical device manufacturers of payments to certain healthcare providers.

For example, under the Physician Payments Sunshine Act provisions of the Affordable Care Act, device manufacturers are subject to federal reporting and disclosure requirements with regard to payments or other transfers of value made to U.S.

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Bribery Act 2010 (the “Bribery Act”), which proscribes giving and receiving bribes in the public and private sectors, bribing a foreign public official, and failing to have adequate procedures to prevent employees and other agents from giving bribes.

companies that conduct business in the United Kingdom generally will be subject to the Bribery Act.

that conduct business in the United Kingdom generally will be subject to the Bribery Act.

Penalties under the Bribery Act include potentially unlimited fines for companies and criminal sanctions for corporate officers under certain circumstances.

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Future environmental laws, rules, regulations or policies may require the Company to alter its manufacturing processes, thereby increasing its manufacturing costs, or may impose other additional obligations on the Company or its products.

The Company believes that its products and manufacturing processes at its facilities comply in all material respects with

applicable environmental laws and worker health and safety laws;

The Company believes that its products and manufacturing processes at its facilities comply in all material respects with applicable environmental laws and worker health and safety laws;

however, the risk of environmental liabilities cannot be completely eliminated.

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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.

What changed 10-K

Item 1. Business