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16 Febbraio 2018

FDA Grants Premarket Approval to New HPV Assay

February 14, 2018 – On February 14, Becton, Dickinson and Company (BD) announced it had received premarket approval from the U.S. Food and Drug Administration (FDA) for the BD Onclarity human papillomavirus (HPV) assay. The test detects 14 types of high-risk HPV from specimens collected for cervical cancer screening from Papanicolaou (Pap) tests in the BD SurePath liquid-based cytology vial. The BD Onclarity HPV assay also identifies HPV genotypes 16, 18, and … (leggi tutto)