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Roche Pre-Cancer Cervical Histology Test Gets FDA Clearance

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.

“By improving the consistency of diagnosis across pathologists, [the test] can help ensure the right patients are receiving the best possible treatment for this highly preventable disease,” Roland Diggelmann, CEO of Roche Diagnostics, said in a statement.

Of the 50 million women screened annually for cervical cancer in the US, nearly all cases can be attributed to human papilloma virus infection, Roche said.

Women testing positive for HPV are at greater risk for pre-cancerous cervical lesions, but physicians can more easily find and treat these lesions before they develop into invasive cancers by doing cervical cancer screening.

When there's an abnormal screening result from a cervical tissue biopsy, Roche's CINtec Histology test provides conclusive visual confirmation of the presence or absence of lesions that could develop into cervical cancer if they are left untreated.

Roche noted that FDA clearance was based on the results generated in the CERTAIN (Cervical Tissue Adjunctive Analysis) study, and that the use of p16 immunohistochemistry to improve the detection of pre-cancerous cervical disease is recommended by the World Health Organization, the College of American Pathologists, and the American Society for Colposcopy and Cervical Pathology. 

The newly cleared test is a part of the Roche cervical cancer portfolio, which includes the Cobas HPV Test and the CINtec Plus Cytology test. The CINtec Histology assay is automated on Roche's Ventana BenchMark IHC/ISH instruments.