Cytology Test for Pre-Cancer Diagnosis Receives FDA Approval

A cytology test, which is the only clinically validated cyclin-dependent kinase inhibitor 2A (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.

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


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. A histology test has received a 510(k) clearance from US Food and Drug Administration. The test plays a key role when a cervical tissue biopsy is taken as a result of an abnormal cervical cancer screening result. The test provides conclusive visual confirmation of the presence or absence of pre-cancerous lesions. These lesions, if untreated, could eventually lead to cervical cancer.

The CINtec PLUS Cytology test uses advanced, dual-biomarker technology to simultaneously detect p16 and antigen Ki-67and 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 Papanicolaou (Pap) cytology primary screening results and helps address some of the limitations of traditional Pap cytology.

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.

Roland Diggelmann, CEO, Roche Diagnostics, said, “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. 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.”