OraSure Technologies Acquires Sherlock Biosciences

OraSure Technologies (Bethlehem, PA, USA), a leader in point-of-need and at-home diagnostic tests and sample management solutions, has acquired Sherlock Biosciences (Watertown, MA, USA), a global health company that develops next-generation diagnostics for consumers and healthcare providers. This acquisition enhances OraSure’s innovation pipeline with the addition of Sherlock’s molecular diagnostics platform, which provides rapid, highly sensitive, and specific results in a disposable format ideal for over-the-counter use.

Sherlock's first molecular self-test targets Chlamydia Trachomatis (CT) and Neisseria Gonorrhoeae (NG), which will broaden OraSure's portfolio of rapid diagnostics for sexually transmitted infections (STIs), pending regulatory approvals. The test promises results in under 30 minutes by analyzing DNA and RNA from self-collected swabs using isothermal amplification. Furthermore, Sherlock is developing a range of molecular tests and next-generation technology platforms, including Ambient Temperature Amplification and CRISPR-based technologies, which could lower costs and improve the performance of its diagnostic platforms.

Image: The addition of Sherlock’s molecular diagnostics platform will expand OraSure’s innovation pipeline (Photo courtesy of Sherlock Biosciences)

Currently undergoing clinical studies, Sherlock’s CT/NG self-test is expected to be submitted to the FDA by the end of 2025 for approval. Pending regulatory clearance, this test is anticipated to drive OraSure's growth, beginning in 2026, through its established infrastructure, commercial capabilities, and robust customer relationships. The total addressable market for CT/NG testing is estimated at over USD 1.5 billion. Presently, most CT/NG tests in the U.S. are processed in centralized laboratories, and the launch of an affordable, fast self-test could significantly expand the market. Additionally, public health channels are crucial to STI screening, an area where OraSure already has a strong presence.

“The acquisition of Sherlock represents the next step in OTI’s innovation strategy,” said Carrie Eglinton Manner, President and CEO of OraSure. “Sherlock brings valuable capabilities with an advanced molecular platform that aims to deliver lab-like accuracy in a format that expands access to diagnostic insights through convenient, effortless tests. We are excited to welcome Sherlock’s talented team to OTI and believe that Sherlock’s unique capabilities will contribute significantly to the expansion of our pipeline of diagnostic tests in infectious disease, sexual health, and beyond.”

Related Links:
OraSure Technologies
Sherlock Biosciences