BD, Franklin Lakes, NJ, has received FDA premarket approval for the BD Onclarity human papillomavirus (HPV) assay. The test detects 14 types of HPV from specimens collected for cervical cancer screening 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.1,2 In evaluating the test, FDA reviewed data collected during a multiyear, prospective, multicenter clinical trial conducted in the United States that included more than 33,500 vaccinated and non-vaccinated 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.3,4 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 decisionmaking.
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.
“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 patients,” says Dave Hickey, president of BD diagnostics systems. “The addition of the BD Onclarity HPV assay to BD’s women’s health and cancer portfolio will enable BD to continue to enhance the standard of patient care, representing the next milestone in cervical cancer screening.”
The BD Onclarity HPV assay is performed on the BD Viper LT system, a benchtop molecular platform that automates sample processing and is also FDA-cleared for chlamydia and gonorrhea infection testing. The BD Onclarity HPV assay achieved the CE mark in 2014, received regulatory approval in Canada and Japan in 2017, and is currently for sale in these and other markets.
- De Sanjose S, Quint WG, Alemany L, et al. Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. Lancet Oncol. 2010;11(11):1048–1056; doi: 10.1016/S1470-2045(10)70230-8.
- Li N, Franceschi S, Howell-Jones R, et al. Human papillomavirus type distribution in 30,848 invasive cervical cancers worldwide: variation by geographical region, histological type, and year of publication. Int J Cancer. 2011;128(4):927–935; doi: 10.1002/ijc.25396.
- Saslow D, Solomon D, Lawson HW, et al. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. J Low Genit Tract Dis. 2012;6(3):175–204; doi:10.1097/LGT.0b013e31824ca9d5.
- Huh WH, Ault KA, Chelmow D, et al. Use of primary high-risk human papillomavirus testing for cervical cancer screening: interim clinical guidance. Gynecol Oncol. 2015;136: 178–182; doi: 10.1097/AOG.0000000000000669.