OraSure withdrew its FDA submission for the InteliQuick CT/NG molecular test, disrupting a planned 2026 launch. In the company’s disclosure, FDA discussions led OraSure to pull the 510(k) and CLIA waiver submission after it concluded clearance would not arrive by the merger-agreement timelines with Sherlock Biosciences. As a result, OraSure expects reduced and recalculated milestone-related obligations tied to the Sherlock acquisition, with the company stating its liability for those milestone payments was reduced to zero. Operationally, the delay also shifts costs related to resubmission, but management said the net effect should be partially offset by the revised milestone structure.
Get the Daily Brief