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BD Gets Pre-market Approval From FDA For BD Onclarity HPV Assay

Becton, Dickinson and Co. (BDX) or BD said that it has received pre-market approval from the U.S. Food and Drug Administration for the BD Onclarity HPV assay.

The test detects 14 types of high-risk human papillomavirus (HPV) from specimens collected for cervical cancer screening or "Pap test" in the BD SurePath liquid based cytology vial.

The BD Onclarity HPV assay also identifies HPV genotypes 16, 18, and 45, which are associated with the majority of cervical cancers worldwide, and are disproportionally responsible for up to 94 percent of glandular cervical cancer cases.

BD plans to seek approval in future submissions for reporting of HPV types beyond 16, 18 and 45 consistent with the extended genotyping capabilities of the assay's design and aligned with evolving cervical cancer screening guidelines.

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