OraSure Technologies withdrew its US FDA submission for its InteliQuick CT/NG point-of-care molecular test following discussions with the agency, removing the planned 510(k) and CLIA waiver submission path. The company said the withdrawal will delay commercialization and cause it to miss a targeted 2026 launch. The regulatory delay also triggers a financial reset for OraSure’s landmark acquisition of Sherlock Biosciences from late 2024. OraSure indicated it is no longer obligated to pay milestone payments tied to FDA clearance for the chlamydia and gonorrhea assay, reducing contingency-related liabilities to zero and recalculating in-process R&D value. OraSure management emphasized ongoing confidence in the test performance and signaled that resubmission costs may be partially offset by the reduction in milestone payments, as described on an investor call and reflected in a recently filed 10-Q.