BD Submits Pre-Market Approval Application to FDA for Onclarity HPV Test

BD submitted a pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the BD Onclarity™ HPV Assay, its human papillomavirus (HPV) test.

The BD Onclarity HPV Assay PMA is supported by data collected during a two-year, prospective, multi-center clinical trial with more than 33,000 women enrolled ― one of the largest clinical trials ever conducted by BD.

The submission seeks approval for use of the BD Onclarity HPV assay* with BD SurePath specimens for detection of 14 high-risk HPV types to determine the need for referral to colposcopy for women 21 and older with abnormal (ASC-US) Pap test results and in women 30 years and older, the use of BD Onclarity together with cervical cytology to adjunctively screen for high-risk HPV and individually identify HPV genotypes 16, 18 and 45. BD is also seeking the use of the test as a first-line primary cervical cancer screening test for women 25 years and older.

BD intends to ultimately seek approval using HPV genotyping beyond 16, 18 and 45, in line with the genotyping capabilities of the assay’s design.

A press release can be found from Becton, Dickinson and Company (BD) Website.