OraSure Technologies
NasdaqGS:OSUR
$
3,08
$
+
$0,02 (0,65%)
3,08
$
+$0,02 (0,65%)
End-of-day quote: 04/08/2026
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OraSure Technologies Company Info
EPS Growth 5Y
-18,61%
Market Cap
$0,21 B
Long-Term Debt
$0,01 B
Short Interest
5,12%
Annual earnings
N/A
Dividend
$0,00
Dividend Yield
0,00%
Founded
2000
Industry
Country
ISIN Number
Website
Analyst Price Target
The Analyst Price Target shows the analysts’ low, high, and average target at a glance.
$5,00
62.34%
Last Update: 04/07/2026
Analysts: 2
Highest Price Target $6,00
Average Price Target $5,00
Lowest Price Target $4,00
In the last five quarters, OraSure Technologies’s Price Target has fallen from $8,88 to $7,40 - a -16,67% decrease. Two analysts predict that OraSure Technologies’s share price will increase in the coming year, reaching $5,00. This would represent an increase of 62,34%.
Top growth stocks in the health care sector (5Y.)
What does OraSure Technologies do?
OraSure Technologies, Inc. (‘OraSure’) develops, manufactures, markets, sales and distributes diagnostics products, and sample management solutions.
The company’s 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.
In December 2024, the company acquired Sherlock Biosciences, Inc. and its subsidiaries (‘Sherlock’). Sherlock is a global health company focused on next-generation...
OraSure Technologies, Inc. (‘OraSure’) develops, manufactures, markets, sales and distributes diagnostics products, and sample management solutions.
The company’s 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.
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 first test for Chlamydia Trachomatis (CT) and Neisseria Gonorrhoeae (NG) is in Phase 3 clinical studies and is expected to be submitted to the U.S. Food and Drug Administration (or the ‘FDA’) for approval by the end of 2025.
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. The company’s 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. 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 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. 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.
Products
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:
OraQuick Rapid HIV Test
The OraQuick Rapid HIV Test is the company’s rapid point-of-care test product designed to test for the presence of HIV-1 and HIV-2 antibodies. This product is sold under the OraQuick ADVANCE name in North America, Europe, and certain other countries, and under the OraQuick name in other developing countries. 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 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. 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 when an initial positive result is obtained. This test is available for use by laboratories located in the United States certified under the 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, finger-stick, and venous whole blood. As a result, the test can be used by numerous additional sites in the United States not certified under CLIA to perform moderately complex tests, such as outreach clinics, community-based organizations, and physicians’ offices.
The OraQuick ADVANCE test is also CE marked for sale in Europe and other countries accepting the CE mark for commercialization. This product is also registered for sale in other countries. The company has distributors in place for several countries and is seeking to increase awareness and expand its distribution network for this product throughout the world. 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 over-the-counter (OTC) oral-fluid-only version of the company’s OraQuick ADVANCE HIV 1/2 Antibody Test. The company received premarket approval (PMA) to sell this test in the U.S. OTC market. 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. 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.
OraQuick HCV Rapid Antibody Test and Self-Test
Another test available on the OraQuick platform is the OraQuick HCV rapid antibody test. This product is a qualitative test that can detect antibodies to the hepatitis C virus (‘HCV’), in a variety of sample types. The OraQuick HCV test operates in substantially the same manner as the OraQuick ADVANCE HIV test.
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. 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. 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. 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. Syphilis Health Check is approved for use with people aged 13 years and older.
OraQuick Ebola Rapid Antigen Test
The company has received De Novo authorization from the FDA for its rapid Ebola test, making it the first and only rapid Ebola test cleared for sale in the U.S. This product utilizes the OraQuick technology platform for the detection of Ebola antigen and can be used with finger-stick and whole blood samples from live patients and oral fluid samples from recently deceased individuals. 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 second-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 2023, the agreement was modified to add an additional $6.8 million in funding to be used to obtain the appropriate regulatory approvals for the product.
InteliSwab COVID-19 Rapid Test
The InteliSwab COVID-19 rapid test (‘InteliSwab’) is the company’s rapid immunoassay product designed to test nasal samples for the presence of antigen from SARS-CoV-2. The device uses an integrated swab to collect a specimen from the lower nostril. After collection, the integrated swab is inserted into a vial containing a pre-measured amount of developer solution to facilitate flow of the sample into the device. The specimen and developer solution flow through the test device and test results are observable in 30 minutes. The InteliSwab test has received an Emergency Use Authorization (‘EUA’) from the FDA for non-prescription, OTC home use in individuals aged two years or older, with symptoms within the first seven (7) days of onset when tested at least twice over a three-day period with at least 48 hours between tests and without symptoms or epidemiological reasons to suspect COVID-19 when tested at least three times over a five-day period with at least 48 hours between tests.
Through 2024, the company maintained its expanded United States production capacity for InteliSwab tests to meet capacity targets set out in its 2021 contract with the U.S. Department of Defense (‘DOD’) (in coordination with the U.S. Department of Health and Human Services (‘HHS’)), of more than 100 million tests annually.
InteliSwab COVID-19 Rapid Test Pro
The InteliSwab COVID-19 Rapid Test Pro is a version of InteliSwab intended for use by healthcare providers at the point of care. The test is performed in the same manner as the OTC version, except that the test is run and interpreted by a healthcare provider. This test has received EUA from the FDA for use by laboratories located in the United States certified under the Clinical Laboratory Improvement Amendments of 1988 (‘CLIA’). The company has also received a CLIA waiver for use of the test, which enables the test to be used by numerous additional sites in the United States, which are not certified under CLIA, to perform high and moderately complex tests. These additional sites include outreach clinics, community-based organizations, and physicians’ offices. This test is also indicated for individuals aged 2 years and older, with and without symptoms of COVID-19.
InteliSwab COVID-19 Rapid Test Rx
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 sells immunoassay tests in formats known as MICRO-PLATE and AUTO-LYTE to meet the specific needs of its customers. The company also sells 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. 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.
Genomic Products
The company sells genomic products that provide all-in-one systems for the collection, stabilization, transportation, and storage of DNA, RNA, as well as both DNA and RNA together from human and animal biological samples. The company’s lead products are sold under the Oragene and ORAcollect brands and are used to collect genetic material from human saliva. These products are currently sold to thousands of academic research and commercial customers in many countries worldwide. The company has obtained FDA clearance for its ORAcollect and its Oragene saliva collection device for general use, including professional and OTC clearances, which allows the company’s commercial partners to use and legally market the device with their assays when used in conjunction with their intended uses.
The company’s genomic products are available in several configurations and contain proprietary chemical solutions optimized for the specific application for which each product is designed. Product physical design is focused on ease-of-use and reliability for self or assisted collection of samples. For example, several of the Oragene products require users to hold the product close to their mouth and spit into the collection device. When the container is closed, the reagents stored in the container’s lid are mixed with the captured saliva and stabilize and preserve the nucleic acids in the sample. This non-invasive collection method yields nucleic acid that remains stable at ambient temperature for extended periods. The stabilizing technology ensures the preservation of high quality and high quantity nucleic acids required for many genetic testing and analysis methods.
These products provide significant advantages over competing DNA and RNA collection methods, such as blood collection or buccal swabs, particularly in human genetic applications.
The company also sells the Colli-Pee collection device for the volumetric collection of first void urine samples. This product is used in liquid biopsy applications for the prostate and bladder cancer markets and in the sexually transmitted infection screening market. 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.
Microbiome Products
The company also markets several microbiome collection products designed to collect, stabilize, and transport the microbial profile from multiple sample types. When unstabilized, a microbiome sample can change when exposed to environmental fluctuations, such as temperature changes. The company’s microbiome collection products support collecting and stabilizing metabolites found in fecal samples by capturing and preserving the microbiome after collection until the desired analysis can be performed.
The company's OMNIgene GUT product is an all-in-one system designed to enable an individual to easily self-collect high-quality microbial DNA from feces or stool samples for gut microbiome profiling for use in the clinical laboratory and research settings. The company's OMNIgene GUT DNA and RNA collection device is available to gut microbiome researchers, allowing for self-collection, stabilization, storage, and transportation of microbial DNA and RNA at ambient temperature for gut microbiome profiling. Most current methodologies for gut microbiome profiling have distinct shortcomings due to the introduction of bias, leading to a lack of reproducibility in the field. The company’s product ensures that the microbial DNA and RNA in the fecal sample are fully stabilized immediately upon collection and maintains an accurate and reliable bacterial profile for weeks at room temperature. In 2023, the company's OMNIgene SALIVA DNA and RNA collection device became available to researchers for self-collection of saliva with stabilization of total nucleic acids. The company's microbiome products also include devices that apply the principles of sample stabilization to other sample types, including oral, skin, and vaginal samples.
The company's OMNIgene GUT Dx collection device received de novo authorization from the FDA for the 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 the 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.
Other Products
In addition to the products, the company offers the following products:
OraSure Collection Device
The company's OraSure oral fluid collection device is used in conjunction with screening and confirmatory tests for HIV-1 antibodies and is FDA approved for use in the detection of HIV-1 antibodies. The company also sells a generic version, which can be used for other analytes. This generic version is a Class I medical device for the detection of cocaine and cotinine in oral fluid specimens for risk assessment testing.
Q.E.D. 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. The U.S. Department of Transportation (‘DOT’) has also approved the test.
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 tests through the first half of 2025, it substantially ceased the production and sale of substance abuse testing products as of the end of 2024.
Products Under Development
Diagnostic Products
The company's research and development efforts include programs targeted at expanding and enhancing its diagnostics business. These programs typically focus on products related to rapid tests for various diseases.
The company is developing a second-generation 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. The company is developing this test and hopes to achieve FDA 510(k) clearance in whole or in part with federal funds obtained from the HHS Administration for Strategic Preparedness and Response (ASPR); BARDA under Other Transaction Number: 75A50123D00005.
Through the company’s Sherlock subsidiary, the company is developing a molecular self-test for Chlamydia Trachomatis (CT) and Neisseria Gonorrhoeae (NG), which is currently in clinical studies. The company acquired this program in connection with its acquisition of Sherlock.
Through the company’s 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. The company acquired this program in connection with its Sherlock acquisition.
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. 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
The company markets its products in the United States and internationally. It attempts to reach major target markets through a combination of direct sales, strategic arrangements, and independent distributors. The company's marketing strategy is to create or raise awareness through a full array of marketing activities, which include trade shows, print advertising, special programs, distributor promotions, telemarketing, and the use of digital and social media in order to stimulate sales in each target market.
Diagnostics – Professional
The company's InteliSwab COVID-19 Rapid Test Pro and Rx products are primarily sold through distributors to U.S. hospitals, physician offices, and clinics. These products are also marketed directly to customers in the public health market, including clinics and laboratories of state, county, and other governmental agencies.
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. 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. The company sells its OraQuick ADVANCE test to hospitals and physician offices in the U.S. primarily through distributors. In addition, the company distributes its OraQuick HIV test in certain foreign countries through distributors.
The OraQuick HCV test is sold primarily to the same markets where the OraQuick ADVANCE HIV test is sold, including public health organizations, hospitals, physicians, and retail clinics. The company also sells this test in other countries through distributors.
The Syphilis Health Check is a CLIA-waived professional test sold for use by clinicians, community health providers, and public health agencies and can be used as an initial screening test or in conjunction with a nontreponemal laboratory test and clinical findings to aid in the diagnosis of syphilis infection.
Diagnostics - OTC and Self-Test
The company sells its InteliSwab COVID-19 Rapid Test product in the U.S. retail and consumer markets, including for purchase by U.S. customers on Walmart's and Amazon’s online stores. 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. military.
The company sells its OraQuick In-Home HIV 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. The product is also available for purchase online through certain retailers and from the company's website, www.oraquick.com. The company also sells its OraQuick HIV Self-Test in certain international markets.
The company's OraQuick HIV Self-Test is the only oral fluid HIV test prequalified by the WHO, and the company's OraQuick HCV Self-Test is the first Hepatitis C self-test prequalified by the WHO. WHO prequalification helps ensure that diagnostic tests for high-burden diseases meet global standards of quality, safety, and efficacy in order to optimize the use of health resources and improve health outcomes. 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
The company's sample management products are sold directly to customers, primarily through its internal sales force in the U.S. markets. However, in many international markets, distributors are used.
Most of the company's revenues from sample management products are derived from sales to commercial customers and sales into the academic and research markets. The company's commercial customers provide consumer genetics and clinical diagnostic services and account for a majority of these revenues. A significant portion of total sales is derived from repeat customers in both markets. The company also has customers in the livestock, companion animal, and pharmaceutical markets.
The company has expanded the market focus of its sample management products by selling certain existing collection products for use in infectious disease testing, including by developing new collection devices for the emerging microbiome market, which is focused on the study of microbial communities and their effect on human health. The company's primary product offering in the microbiome market, OMNIgene GUT, is focused on the human gut microbiome (microbes living in human stool). The company is leveraging its existing sales force and global research connections to engage microbiome customers around the world and establish itself as among the leaders in ease-of-collection, stabilization, and transport of microbiome communities in a variety of challenging sample types, such as stool, skin, vaginal, and oral.
The company's products include the Colli-Pee collection device 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 for use in the liquid biopsy and sexually transmitted disease markets. 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.
Customers
One non-commercial customer accounted for approximately 24% of the company's consolidated net revenues for the year ended December 31, 2024.
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. 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 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. Other companies would be able to assemble these OraQuick tests on terms no less favorable than those set forth in the agreement if the Thailand contractor would be unable or unwilling to continue assembling this product. The company has long-term agreements in place for contract manufacturing in Thailand, and one of its suppliers, which has been pre-qualified by the WHO, has been manufacturing for the company for the past 20 years.
The company can purchase the HIV antigens, the nitrocellulose, and certain other critical components, and the HCV and Ebola antigens used in its OraQuick product lines only from a limited number of sources.
The company manufactures all of the proprietary chemistry and assay cards for its InteliSwab COVID-19 Rapid Tests in its Bethlehem, Pennsylvania facilities. The company significantly scaled up manufacturing capacity in the United States for its InteliSwab COVID-19 Rapid Tests and achieved manufacturing capacity targets under its 2021 contract with the U.S. DOD, in coordination with the HHS. The company's Opus Way facility was customized to accommodate increased manufacturing capacity. Throughout 2024, 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.
DNAG has three long-term contract manufacturing relationships to supply virtually all of its products, including the Oragene product line. 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. The company is actively seeking to qualify other suppliers that can manufacture and supply the raw materials and components for the DNAG products. 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.
Patents and Proprietary Information
The company has the U.S. and international PCT patent applications that are directed to a new developer solution vial for use with sampling and assay devices. The international application entered its national phase in countries throughout the world in May 2023, and patents issuing from these applications are expected to expire in December 2041. 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.
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 U.S. and corresponding design applications were registered in Canada, China, India, and Europe. These design patents will expire in 2038 and 2039.
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. 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.
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. This patent expires in April 2034. The company has also applied for additional patents and designs, in both the United States and certain foreign countries, in novel urine collection devices.
The company owns rights to trademarks and service marks that 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 i2he, 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. The company also owns many of these marks and others in several foreign countries and it is pursuing registration of several other trademarks.
Trademarks, Trade Names, and Service Marks
The company owns rights to trademarks and service marks that 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 i2he, 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. The company also owns many of these marks and others in several foreign countries and it pursues the registration of other trademarks where appropriate.
Government Regulation
Most of the company's products are regulated by the FDA, along with other federal, state, and local agencies and comparable regulatory bodies in other countries.
The company considers the applicability of CLIA requirements in the design and development of its products. 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. 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.
The company is also subject to regulations in foreign countries governing products, human clinical trials, and marketing, and may need to obtain approval (or pre-qualification or endorsement) from local regulators in such countries or international public health agencies, such as the World Health Organization, in order to sell products in certain countries.
The International Organization for Standardization (‘ISO’) is a worldwide federation of national standards bodies. ISO 13485 certification indicates that the company's quality system complies with standards applicable to activities ranging from initial product design and development through production and distribution.
The company must also comply with certain registration and licensing requirements as dictated by Health Canada, prior to commencing sales in Canada. The company has obtained WHO pre-qualification for its OraQuick HIV-1/2 Antibody Test, OraQuick HIV Self-Test, OraQuick HCV Rapid Antibody Test, and OraQuick HCV Self-Test.
The company has implemented a written policy on interactions with health care professionals, which is based on the Code of Ethics for Interactions with Health Care Professionals promulgated by the Advanced Medical Technology Association (‘AdvaMed’), a leading trade association representing medical device manufacturers.
The U.S. Foreign Corrupt Practices Act (‘FCPA’), to which the company is subject, prohibits corporations and individuals from engaging in bribery and corruption when dealing with foreign government officials and foreign political parties.
The laws to which the company is subject as a result of its international sales also include the U.K. 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.
Products that the company sells in Europe are subject to regulation in EU markets under the Directive on the Restriction of the Use of Certain Hazardous Substances (‘RoHS’).
Research and Development
The company’s research and development expenses decreased to $26.0 million for the year ended December 31, 2024.
History
OraSure Technologies, Inc., a Delaware corporation, was founded in 2000. The company was incorporated in 2000.
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