OraSure Technologies withdrew its FDA submission and CLIA waiver request for the InteliQuick CT/NG point-of-care molecular test after discussions with the agency. The decision removes the timing assumption for a 2026 launch and alters milestone economics tied to OraSure’s 2024 acquisition of Sherlock Biosciences. Coverage says OraSure’s liability for milestone payments was reduced to zero, and the revised delay also triggered a recalculation of in-process R&D value in a recent SEC filing. OraSure leadership characterized the company as confident in test performance and plans resubmission work to recover regulatory clearance. The development matters for biotech buyers and diagnostics investors because it shows how regulatory friction can directly swing cash-flow-linked deal terms.