NEW YORK (360Dx) – Roche said today that it has received 510(k) clearance from the US Food and Drug Administration for its CINtec Histology test for cervical pre-cancer.

When used in conjunction with hematoxylin and eosin (H&E) staining, CINtec Histology is the only clinically validated p16 biomarker test that helps pathologists determine which women should receive treatment for cervical pre-cancer, Roche said.