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# BD PMA Supplement to Expand HPV Assay
- URL: https://www.fdaweb.com/bd-pma-supplement-to-expand-hpv-assay/
- Published: 2019-11-12T12:00:00.000Z
- Updated: 2026-09-14T15:52:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145479

Becton Dickinson (BD) has submitted a PMA supplement for an expanded version of its BD Onclarity HPV Assay. The device detects 14 types of high-risk human papillomavirus (HPV) from specimens collected for cervical cancer screening in the BD SurePath Collection Vial. The submission includes data collected during a three-year follow up of subjects from BD’s prospective, multi-center clinical trial conducted in the U.S. that included more than 33,500 women, including those who received HPV vaccines and those who did not.

  
The company says the device is the only FDA-approved assay to individually identify and report HPV genotypes 16, 18, and 45, which are “associated with the majority of cervical cancers worldwide and are disproportionally responsible for up to 94% of glandular cervical pre-cancer cases. The prevalence of HPV genotypes 16 and 18, which are among those targeted by FDA-approved HPV vaccines, are decreasing in vaccinated populations; thus shifting the prevalence of cervical pre-cancer cases to other HPV genotypes.”