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. The company said the regulatory delay will push clearance beyond its targeted 2026 launch timeline. The withdrawal also affects milestone payments tied to OraSure’s acquisition of Sherlock Biosciences in late 2024, reducing milestone-related liability to zero in updated disclosures. OraSure’s CEO characterized the test as “first-of-its-kind” and performing well, while the CFO noted resubmission would create incremental costs. The decision highlights how regulatory timelines for fast molecular assays can directly reshape deal economics and commercialization plans.