OraSure Technologies withdrew its FDA 510(k) and CLIA waiver submission for the InteliQuick CT/NG point-of-care molecular test after discussions with the agency. The withdrawal will delay commercialization, pushing clearance beyond the company’s previously targeted 2026 launch timeline. OraSure said the regulatory delay also affects milestone economics tied to its 2024 acquisition of Sherlock Biosciences. With the submission withdrawn, the company reported it is no longer obligated to make the associated milestone payments, reducing related liabilities. The test uses isothermal nucleic acid amplification to detect Chlamydia trachomatis and Neisseria gonorrhoeae in about 30 minutes, designed for point-of-care and at-home settings. For in vitro diagnostics developers, the case shows how FDA submission strategy and agency feedback can reshape both product timing and transaction-related milestone structures.