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BD Files for FDA Approval of HPV Assay

NEW YORK (GenomeWeb) – Becton Dickinson announced today that it has submitted a pre-market approval application with the US Food and Drug Administration for its Onclarity HPV assay for human papillomavirus.

The submission is based on data collected during a two-year prospective study of more than 33,000 women, according to BD. It seeks approval to use the assay — which is designed to run on the BD Viper LT RT-PCR system — with BD SurePath specimens for the detection of 14 high-risk HPV types to determine the need for colposcopy for women 21 years and older with abnormal pap test results.

BD is also seeking approval for use of the test in women 30 years and older in conjunction with cervical cytology to adjunctively screen for high-risk HPV and individually identify virus subtypes 16, 18, and 45, as well as its use as a first-line primary cervical cancer screening test in women 25 years and old.

BD said that it intends to later seek FDA approval for the Onclarity HPV assay using genotyping beyond subtypes 16, 18, and 45.