OraSure Technologies, Inc.

OTI develops, manufactures, markets, sells, and distributes diagnostic products and sample management solutions. The company operates under a single business unit with one reporting hierarchy, encompassing commercial and innovation teams across multiple product lines. Its diagnostic products include simple, easy-to-use tests and specimen collection devices utilizing proprietary technologies, as well as other diagnostic products like immunoassays and in vitro diagnostic tests for various specimen types. These rapid point-of-care tests cover diseases such as HIV, Hepatitis C virus (HCV), Syphilis, Sickle Cell, and COVID-19. OTI's products are sold in the United States and internationally to clinical laboratories, hospitals, clinics, community-based organizations, public health organizations, distributors, government agencies, physicians' offices, and commercial and industrial entities. HIV and COVID-19 products are available in a consumer-friendly format in the U.S. over-the-counter (OTC) market. HIV and HCV products are also sold as self-tests in other countries; specifically, HIV products are offered as an oral swab in-home test for HIV-1 and HIV-2 in Europe, and HCV products as an OTC test. In November 2025, OTI acquired BioMedomics, Inc., which developed the SickleSCAN® test, the first rapid point-of-care test for sickle cell disease, currently sold outside the U.S. In December 2025, OTI submitted a 510(k) premarket notification to the FDA for its rapid molecular self-test for Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG), which is under review. The company's sample management solutions and services are used by clinical laboratories, direct-to-consumer laboratories, researchers, pharmaceutical companies, and animal health service and product providers.