The U.S. Food and Drug Administration proposed reclassifying certain companion diagnostic (CDx) assays from Class III to Class II, which would allow some oncology nucleic‑acid‑based tests to follow the 510(k) pathway rather than premarket approval. The draft order covers nucleic‑acid amplification and sequencing tests indicated for use with an approved oncology therapeutic. Industry stakeholders told reporters the change could lower regulatory barriers and speed market entry for smaller diagnostics firms, increase lab participation in companion testing and reduce development costs. The FDA emphasized that special controls would remain in place to assure safety and effectiveness, including performance standards and postmarket surveillance. Diagnostic companies, pharma partners and payers will assess how a reclassification could alter co‑development strategies and the economics of assay deployment alongside targeted therapies.