FDA Grants Premarket Approval to New HPV Assay

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 45, which are associated with the majority of cervical cancers worldwide, and are disproportionately responsible for up to 94% of glandular cervical cancer cases.

In evaluating the test, the FDA reviewed data collected during a multiyear, prospective, multicenter clinical trial conducted in the United States that included more than 33,500 vaccinated and nonvaccinated women.

The BD Onclarity HPV assay may be used in accordance with clinical guidelines for cervical cancer screening and management to identify the presence of high-risk HPV types. 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 provides information that together with the physician's assessment and professional guidelines, may be used to inform clinical decision-making.  

BD intends 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.

Thomas C. Wright, Jr, MD, Professor Emeritus of Pathology and Cell Biology at Columbia University, said, “The approval of the BD Onclarity HPV assay provides clinicians and laboratories an FDA-approved option for HPV primary screening with the BD SurePath liquid-based cytology vial. The BD Onclarity HPV assay also aligns with clinical screening guidelines from the American Cancer Society, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology.”

The BD Onclarity HPV assay is performed on the BD Viper LT system, a bench-top molecular platform that automates sample processing and is also FDA-cleared for chlamydia and/or gonorrhea infection testing. The BD Onclarity HPV assay achieved the European CE mark for in vitro diagnostics in 2014, received regulatory approval in Canada and Japan in 2017, and is currently for sale in these and other markets.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.




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