BD Submits Pre-Market Approval Supplement to FDA for BD Onclarity™ HPV Test with Extended Genotyping Capabilities

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Nov 12, 2019, 06:59 ET

FRANKLIN LAKES, N.J., Nov. 12, 2019 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that it has submitted a pre-market approval (PMA) supplement to the U.S. Food and Drug Administration (FDA) for an expanded version of its BD Onclarity™ HPV Assay.

The FDA-approved BD Onclarity™ HPV Assay detects 14 types of high-risk human papillomavirus (HPV) from specimens collected for cervical cancer screening in the BD SurePath™ Collection Vial. The BD Onclarity™ HPV Assay is the only FDA-approved assay to individually identify and report HPV genotypes 16, 18, and 45. These genotypes are associated with the majority of cervical cancers worldwide and are disproportionally responsible for up to 94 percent of glandular cervical pre-cancer cases.^1,2The prevalence of HPV genotypes 16 and 18, which are among those targeted by the FDA-approved HPV vaccines, are decreasing in vaccinated populations; thus shifting the prevalence of cervical pre-cancer cases to other HPV genotypes.³

The PMA supplement seeks approval for genotype reporting beyond HPV genotypes 16, 18, and 45 to include types 31, 51, 52, and 8 additional types. The FDA submission includes data collected during a three year follow up of subjects from BD's prospective, multi-center clinical trial conducted in the U.S. that included more than 33,500 women, including those who received HPV vaccines and those who did not.

"Our goal is to provide laboratories and clinicians worldwide with comprehensive cervical cancer screening solutions that address the unique needs of individual healthcare providers and precision medicine for patients," said Dave Hickey, president, BD Integrated Diagnostic Solutions. "This PMA submission is the next step in our roadmap for the BD women's health and cancer portfolio as it brings us one step closer to expanding access to extended HPV genotyping capabilities in the U.S. market."

About BD Onclarity^™ HPV Assay

The BD Onclarity^™ HPV Assay detects and identifies 14 high-risk human papillomavirus (HPV) types and provides genotyping information from specimens collected for cervical cancer screening purposes in the BD SurePath^™ Collection Vial and in the Hologic PreservCyt^® Solution (not approved in the United States). The assay can be used in accordance with clinical guidelines and within the scope of local regulatory authorizations as part of a comprehensive approach to cervical cancer prevention. Different configurations of the test are CE marked and FDA approved.

About BD

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of healthcare by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for healthcare providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to healthcare.

References

1. de Sanjose S, Quint WG, Alemany L, Geraets DT, Klaustermeier JE, et al. (2010). Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. The Lancet Oncology, 11(11): 1048-56.

2. Li N, Franceschi S, Howell-Jones R, Snijders P J & Clifford GM. (2011). Human papillomavirus type distribution in 30,848 invasive cervical cancers worldwide: Variation by geographical region, histological type and year of publication. International Journal of Cancer, 128(4), 927-35.

3. Wright Jr TC, Parvu V, Stoler MH, Kodsi S, Eckert K, Yanson K, Cooper CK. (2019). HPV infections and cytologic abnormalities in vaccinated women 21–34 years of age: Results from the baseline phase of the Onclarity trial. Gynecologic Oncology, 153:259-265.

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