FDA Approves Onclarity HPV Assay for Use with BD SurePath Liquid-based Pap Test, Hologic ThinPrep Pap Test

The Onclarity human papillomavirus (HPV) Assay from BD has received FDA marketing approval for its use with both the BD SurePath Liquid-based Pap Test and the Hologic ThinPrep Pap Test, expanding its use to more precisely identify patients’ risk for cervical cancer.

The BD SurePath Liquid-based Pap Test vial and the Hologic ThinPrep Pap Test PreservCyt Solution vial are the 2 most common pap vials used by laboratories in the United States. According to a BD press release, including the ThinPrep Pap Test improves access to the benefits of the HPV assay, which is the only FDA-approved assay that tests for an extended set of HPV types individually.

In particular, the assay tests for HPV31, a specific type of HPV that poses a high risk for causing cervical cancer. Identifying HPV31 individually can help better determine risk for cervical pre-cancer, which can lead to different clinical decision-making and different options than when assessing risk with multiple genotypes reported collectively, according to BD.

“Most tests report multiple HPV types in a single pooled result, which can mask the true risk of developing cervical cancer,” said Brooke Story, worldwide president of Integrated Diagnostics Solutions for BD, in a press release. “Being able to identify high-risk HPV31 individually is critical to the detection and prevention of cervical cancer. HPV31 poses the second-highest risk for cervical pre-cancer, and the BD Onclarity HPV Assay is the only FDA-approved assay that screens for it individually.”

The evidence generation for the clinical validation of the BD Onclarity HPV Assay out of PreservCyt media was achieved by one of the largest real-world evidence studies of its kind, including a random sample of 19,879 women’s preserved samples who had undergone opportunistic cervical screening and follow-up in routine clinical practice, with known clinical outcomes.

The BD Onclarity HPV Assay detects and identifies 14 high-risk HPV types in a single analysis. It reports genotypes beyond HPV types 16, 18, and 45 to include types 31, 51, 52, 33/58, 35/39/68, and 56/59/66, making it the only FDA-approved assay to individually identify and report these genotype results.

It has FDA approval for use in vaccinated women. As the previously vaccinated subpopulation ages, the screening population will progressively include women with reduced prevalence of HPV 16 and 18, increasing the value of extended genotype reporting in a mixed population of vaccinated and unvaccinated women.

“Cervical cancer is preventable,” said Jeff Andrews, MD, FRCSC, vice president of medical affairs for BD, in the press release. “When more people with a cervix are better able to manage their health through more accurate and precise testing, we are taking another step forward toward eliminating cervical cancer in our lifetimes.”

The ThinPrep Pap Test with the BD Onclarity HPV Assay can be used on the BD COR or BD Viper LT instrument platforms without changing current cytology equipment. The BD COR System has integrated and automated workflows, and the extended claim for the BD Onclarity HPV Assay allows mid- to low-throughput labs to leverage the BD Viper LT instrument to enhance HPV test offerings.

REFERENCE

BD Onclarity HPV Assay Receives FDA Approval for Use with Both BD SurePath Liquid-based Pap Test and Hologic ThinPrep Pap Test. News release. BD; February 21, 2023. Accessed February 22, 2023. https://news.bd.com/2023-02-21-BD-Onclarity-TM-HPV-Assay-Receives-FDA-Approval-for-Use-with-Both-BD-SurePath-TM-Liquid-based-Pap-Test-and-Hologic-ThinPrep-R-Pap-Test