Roche has received FDA marketing clearance for the CINtec Histology test. The p16 biomarker test, when used in conjunction with hematoxylin & eosin (H&E) staining, helps pathologists determine which women should receive treatment for cervical pre-cancer.

The test is a part of Roche’s cervical cancer portfolio, which also includes the Cobas HPV test and the CINtec plus cytology3 test.

The clearance was based on the results from a clinical study demonstrating the effectiveness of the portfolio.  — Cynthia Jessup