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Roche Cervical Pre-Cancer Test Garners FDA Approval

NEW YORK – Roche announced Wednesday that its CINtec Plus Cytology test for women with the human papillomavirus infection who are at risk of cervical cancer has been approved by the US Food and Drug Administration.

The biomarker-based triage test identifies women whose HPV infections are most likely to be associated with cervical pre-cancers after they've tested positive for HPV. It's used in combination with the Roche Cobas 4800 HPV test and CINtec Histology and detects the presence of two biomarkers, p16 and Ki-67, that signal a woman is more significantly at risk for cervical cancer. The test uses the same liquid sample used for HPV or Pap cytology testing, the company said.

The test, which runs on the BenchMark Ultra IHC/ISH system, was approved by the FDA to triage women with HPV-positive and Pap cytology-negative co-testing results.

The test provides info to clinicians about which HPV-positive women may benefit from immediate colposcopy instead of repeat testing, Roche said. Most HPV infections resolve on their own, but some women who test positive for HPV or have inconclusive co-testing results can develop pre-cancerous cervical lesions that could progress to cancer, the company added.

Basel, Switzerland-based Roche said the test will likely be commercially available in the US later this year, and publication of study data to clinically validate the CINtec Plus Cytology test in different screening scenarios is pending. The test has been used as a triage test for HPV-positive results and mildly abnormal Pap cytology results in Europe, Asia, South America, and Australia.