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Basel Roche today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (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.

"The CINtec Histology test will help physicians make informed decisions as to the best course of care for patients with high-grade pre-cancerous cervical disease," said Roland Diggelmann, CEO, Roche Diagnostics. "By improving the consistency of diagnosis across pathologists, it can help ensure the right patients are receiving the best possible treatment for this highly preventable disease."

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 CERTAIN4 (Cervical Tissue Adjunctive Analysis) study, which now joins the landmark ATHENA5 and PALMS6 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. About the Roche Cervical Cancer Portfolio

The Roche Cervical Cancer Portfolio enables healthcare professionals to better screen, manage and diagnose women, based on the confidence and clarity of results across a continuum of patient care. The unique combination of molecular, cellular and tissue-based diagnostic tests provides healthcare professionals powerful information to make patient care decisions and minimize unnecessary treatment. Human Papillomavirus (HPV) is the known cause of cervical cancer and is used to identify women at risk. cobas HPV testing is clinically validated for HPV primary screening, ASC-US triage, and co-testing (HPV and Pap cytology) using the cobas 4800 or cobas 6800/8800 Systems7. The assays provide specific genotyping information for HPV16 and HPV18, the highest-risk types, while simultaneously reporting the 12 other high-risk HPV types as a pooled result, all in one test and from one patient sample.

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. About Human Papillomavirus and cervical cancer

Persistent infection with high-risk Human Papillomavirus (HPV) is the principal cause of cervical cancer in women, with HPV implicated in greater than 99 percent of cervical cancers worldwide.

It can take 10 to 15 years or longer for cervical cancer to develop, so knowing a woman's individual risk and finding disease early, before cancer develops, is an important prevention strategy. The World Health Organization (WHO) estimates there are more than 500,000 new cases of cervical cancer annually.