On April 4, 2017 Roche (SIX: RO, ROG; OTCQX:RHHBY) reported it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the CINtec Histology test (Press release, Hoffmann-La Roche, APR 4, 2017, View Source [SID1234518467]). 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.

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"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.