OraSure Technologies develops, manufactures, and sells rapid point-of-care diagnostic tests and biological sample collection devices. The core product is the OraQuick platform — a family of rapid tests for HIV, Hepatitis C, and Syphilis that uses an oral fluid swab rather than blood, delivering results in 20-40 minutes. OraQuick is sold in two formats: professional (clinics, hospitals, public health organizations, government agencies) and OTC directly to consumers. OraQuick's HIV Self-Test is the only FDA-approved oral fluid HIV test available OTC in the U.S., and OraQuick is also the only FDA-approved rapid HCV test in the U.S. The second business, Sample Management Solutions, operates under the DNA Genotek brand and makes collection devices that allow people to provide saliva, urine, fecal, or other biological samples remotely. Proprietary chemical solutions stabilize these samples at room temperature, enabling labs and researchers to receive high-quality biological material collected outside clinical settings. Customers include consumer genetics companies, clinical labs, pharma and biotech firms, and academic researchers. Both segments sell single-use consumables that generate repeat purchases. Gross margins run in the low-to-mid 40% range, with meaningful R&D spend on a new molecular diagnostics platform (Sherlock) targeting an OTC rapid test for chlamydia and gonorrhea, with FDA submission filed in late 2025 and a mid-2026 launch targeted.