The Onclarity HPV test is supported by data collected during a two-year prospective, multi-center clinical trial (NCT01944722) with more than 33,000 women enrolled. The test is designed to provide physicians with detailed HPV genotype information, reporting six discrete HPV genotypes (16, 18, 31, 45, 51, and 52) and three small groups: (33, 58), (35, 39, 68), and (56, 59, 66), to guide informed treatment decisions.
“The submission of BD’s HPV PMA application marks the completion of a significant undertaking,” Doug White, vice president and general manager of BD’s Women’s Health & Molecular Diagnostics, said in a press release. “Our goal is to provide clinical laboratories and clinicians with comprehensive cervical cancer screening solutions that include BD Onclarity HPV Assay, BD SurePath Pap Test and BD Totalys System processing automation.”
BD pre-market approval application seeks consent to use the Onclarity test as a first-line cervical cancer screening for women who are at least 25 years old.
In addition, BD is seeking to use Onclarity with specimens collected in SurePath, a BD preservative fluid, for detection of 14 high-risk HPV types, to determine the need for referral of colposcopy for women 21 or older who have abnormal Pap test results. Colposcopy is a procedure that closely examines a woman’s cervix, vagina and vulva for signs of disease.
The submission also requests approval of Onclarity for use in women 30 and older, in conjunction with cervical cytology, to screen for high-risk HPV and individually identify HPV genotypes 16, 18 and 45.
Finally, the submission seeks approval to use the assay on the BD Viper LT System, a bench-top molecular platform currently FDA-approved for chlamydia gonorrhea infection testing. The Viper test requires minimal user intervention and is included in the BD Totalys System, which automates cervical cancer screening.
The company intends to see the assay’s capabilities ultimately approved for use in HPV genotyping beyond 16, 18 and 45.