Pre-market FDA approval for BD Onclarity HPV assay to detect HPV genotypes 16, 18, and 45, associated with the majority of cervical cancers . BD Diagnostics.
BD (Becton, Dickinson and Company) a leading global medical technology company, announced that it has received pre-market approval from the FDA for the BD Onclarity HPV assay.
The test detects 14 types of high-risk human papillomavirus (HPV) from specimens collected for cervical cancer screening ("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.
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