OraSure Technologies withdrew its FDA 510(k) and CLIA waiver submission for its InteliQuick CT/NG point-of-care molecular test after discussions with the agency, pushing the expected clearance timeline out to beyond end of 2026. The withdrawal is tied to milestone payment terms in OraSure’s acquisition of Sherlock Biosciences from late 2024. OraSure said it will miss its targeted 2026 launch, reducing contingency milestone-related income and setting its liability for the milestones to zero. The test uses isothermal nucleic acid amplification to detect Chlamydia trachomatis and Neisseria gonorrhoeae in about 30 minutes for point-of-care and at-home settings. Company leadership told investors it remains confident the test performs well, while management flagged incremental costs tied to a future resubmission. The change highlights how FDA interactions can directly affect deal economics and commercialization timing.