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OraSure Seeks FDA Clearance for New STI Tests

Story Highlights
  • OraSure has sought FDA clearance for a rapid CT/NG self-test and Colli-Pee at-home STI urine collection device, following submissions made at the end of 2025.
  • The company aims to expand decentralized STI diagnostics with a 30-minute over-the-counter molecular test and an enhanced Colli-Pee offering, targeting a CT/NG market it values above $1.5 billion and strengthening its leadership in at-home testing solutions.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
OraSure Seeks FDA Clearance for New STI Tests

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Orasure Technologies ( (OSUR) ) has issued an update.

On January 5, 2026, OraSure Technologies reported that at the end of 2025 it submitted two applications to the U.S. Food and Drug Administration seeking clearance for a rapid molecular self-test for Chlamydia trachomatis and Neisseria gonorrhoeae and for its Colli-Pee at-home urine collection device for sexually transmitted infections. The CT/NG self-test, built on the Sherlock molecular diagnostics platform, is designed as a disposable, over-the-counter product that delivers results in about 30 minutes from a self-collected swab without requiring an electrical connection, targeting a U.S. testing market the company estimates exceeds $1.5 billion, which is currently dominated by centralized laboratory testing. The Colli-Pee device, already available for research use only, is intended to support private, convenient at-home urine collection for multiple STI indications in collaboration with a leading diagnostics platform provider, and FDA clearance would expand access to STI testing and reinforce OraSure’s positioning in decentralized diagnostics and novel sample collection technologies.

The most recent analyst rating on (OSUR) stock is a Hold with a $2.50 price target. To see the full list of analyst forecasts on Orasure Technologies stock, see the OSUR Stock Forecast page.

Spark’s Take on OSUR Stock

According to Spark, TipRanks’ AI Analyst, OSUR is a Neutral.

Orasure Technologies’ overall stock score is primarily impacted by its financial performance challenges, including negative profitability and cash flow issues. While strategic initiatives and a strong balance sheet provide some optimism, the bearish technical indicators and poor valuation metrics weigh heavily on the score.

To see Spark’s full report on OSUR stock, click here.

More about Orasure Technologies

OraSure Technologies, Inc., based in Bethlehem, Pennsylvania, is a diagnostics company focused on point-of-need and at-home testing and sample management solutions. Through its subsidiaries DNA Genotek, Sherlock Biosciences and BioMedomics, the company develops, manufactures and distributes rapid diagnostic tests and sample collection and stabilization devices for critical medical conditions, selling globally to clinical laboratories, hospitals, physicians, clinics, public health organizations, research institutions, government agencies, pharmaceutical companies and directly to consumers.

Average Trading Volume: 659,252

Technical Sentiment Signal: Sell

Current Market Cap: $170.7M

Learn more about OSUR stock on TipRanks’ Stock Analysis page.

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