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 move pushes the company’s planned 2026 launch out, and it eliminates milestone payment obligations tied to the Sherlock Biosciences acquisition. OraSure said it elected the withdrawal in July and now expects clearance no earlier than after 2026, based on updated resubmission timing. In a related SEC disclosure, the company reduced its liability for contingent milestone payments to zero. The update also affects in-process R&D valuation and royalty-related contingency consideration, illustrating how regulatory timelines can directly change financing and acquisition economics for diagnostics companies.