FDA grants 510(k) clearance for the CINtec Histology test to determine which women should receive treatment for cervical pre-cancer. Roche

Roche has announced it has received 510(k) clearance from the FDA for the CINtec Histology test. This test is the only clinically validated p16 biomarker test that, when used in conjunction with hematoxylin & eosin (H&E) staining, helps pathologists determine which women should receive treatment for cervical pre-cancer. This test is a part of the Roche Cervical Cancer Portfolio, which includes the cobas HPV Test and the CINtec PLUS Cytology3 test. As women positive for HPV are at greater risk for having or developing pre-cancerous cervical lesions, cervical cancer screening can help physicians find and treat these pre-cancerous lesions before they develop into invasive cancers.

The CINtec Histology test plays a key role when a cervical tissue biopsy is taken as a result of an abnormal cervical cancer screening result, as it provides conclusive visual confirmation of the presence or absence of pre-cancerous lesions. These lesions, if untreated, could eventually lead to cervical cancer. FDA clearance was based on the results generated in the CERTAIN 4 (Cervical Tissue Adjunctive Analysis) study, which now joins the landmark ATHENA 5 and PALMS 6 trials in demonstrating the effectiveness of the products within the Roche Cervical Cancer Portfolio. Additionally, the use of p16 immunohistochemistry is recommended by the World Health Organization (WHO), the College of American Pathologists (CAP) and the American Society for Colposcopy and Cervical Pathology (ASCCP) to improve the detection of pre-cancerous cervical disease.

Using advanced, dual-biomarker technology to simultaneously detect p16 and Ki-67, the CINtec PLUS Cytology3 test identifies transforming HPV infections, providing greater certainty to clinicians to stratify patients for follow-up or intervention. The CINtec PLUS Cytology test is an objective triage solution for managing HPV-positive or abnormal Pap cytology primary screening results and helps address some of the limitations of traditional Pap cytology. The CINtec PLUS Cytology test is not available as an in vitro diagnostic test in the United States. The CINtec Histology test is used to confirm the presence or absence of high-grade cervical disease in women who have had a tissue biopsy. The CINtec Histology test uses the p16 biomarker for a more conclusive diagnosis to provide distinctive visual confirmation of pre-cancerous cervical lesions which may be missed by H&E interpretation alone. Both CINtec assays are fully automated on the VENTANA BenchMark IHC/ISH instruments.