Medical technology company BD (Becton, Dickinson and Company) (NYSE:BDX) reported on Tuesday the receipt of pre-market approval from the US Food and Drug Administration (FDA) for the BD Onclarity HPV assay for cervical cancer screening and management to identify the presence of high-risk HPV types.
The company added that the Pap test detects 14 types of high-risk human papillomavirus (HPV) from specimens collected for cervical cancer screening in the BD SurePath liquid based cytology vial. The BD Onclarity HPV assay identifies HPV genotypes 16, 18, and 45 responsible for up to 94% of glandular cervical cancer.
In conjunction, the US FDA has reviewed the data collected from multi-year, prospective, multi-centre clinical trial conducted in the US that included about 33,500 vaccinated and non- vaccinated women. The test is clinically validated for use as a primary screening test, for triaging patients with abnormal Pap test results and to be used in combination with a Pap test. The BD Onclarity HPV assay is performed on the BD Viper LT system, a bench top molecular platform.
According to the company, it 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.
Additionally, the company's BD Onclarity HPV assay has achieved the European CE-IVD mark in 2014, received regulatory approval in Canada and Japan in 2017, and is currently for sale in these and other markets.
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