FDA Approves HPV Test With Extended Genotyping Capabilities

July 24, 2020

The expanded version of the BD Onclarity HPV Assay received approval for a pre-market approval supplement from the FDA, making it the only assay approved right now that individually identifies and reports human papillomavirus genotypes 31, 51, 52, 33/58, 35/39/68, and 56/59/66, as well as the standard 16,18, and 45.

The expanded version of the BD Onclarity™ HPV Assay received approval for a pre-market approval supplement from the FDA, making it the only assay approved right now that individually identifies and reports human papillomavirus (HPV) genotypes 31, 51, 52, 33/58, 35/39/68, and 56/59/66, as well as the standard 16,18, and 45, announced the Becton, Dickinson and Company (BD), in a press release.

For patients with HPV, this assay can detect and identify 14 HPV types in a single analysis. This approval encompasses the clinical use of the BD Onclarity™ HPV Assay in cytology-based screening with ASC-US (atypical squamous cells of undetermined significance)triage, co-testing paradigm, and primary HPV screening. The specimens collected for cervical cancer screening purposes in the BD SurePath™ Collection Vial and in the Hologic PreservCyt®, which is not approved in the United States, will deliver genotyping information.

"BD Onclarity™ extended genotyping is data-driven precision medicine at its best, helping us effectively and efficiently manage our patients," Mark H. Stoler, MD, professor emeritus of pathology at the University of Virginia Health System, said in a statement. "Contemporary management of women with abnormal cervical cancer screening results demands an assessment of their risk of pre-cancer. An abundance of recent science clearly shows that knowing the HPV genotype of the patient provides excellent differential stratification of those risks."

Clinical studies have shown value in having extended genotyping for cervical cancer screening and triage since 2015, according to BD. Since 2016, there has been an acknowledgment of the need for expanded HPV genotyping.

In April of this year, the ASCCP risk-based management consensus guidelines predicted that extended genotyping would be announced soon. HPV genotypes with screened test results being reported could improve risk stratification and support risk-based patient management in many cases.

"It is well known that different HPV genotypes carry different risk of cervical cancer, and without the specific knowledge of the HPV genotype in a screening sample many women will be over-treated needlessly," Jesper Bonde, PhD, senior researcher and molecular pathology laboratory manager at Hvidovre Hospital in Denmark, said in a press release. "Screening strategies that employ HPV tests with simultaneous genotyping offer a simple way to improve cervical cancer screening to the benefit of the woman and health care providers by allowing risk stratification already on the screening sample."

This approval will aid same-genotype persistence tracking and risk-based management through the reporting of HPV genotypes with the screening tests and surveillance tests. Being able to keep track of patients’ HPV genotype will allow physicians to monitor patients and predict relapses depending on the testing results.

"With this FDA approval, BD can now offer laboratories, clinicians, and patients access to critical information in screening for cervical cancer in the United States and other countries recognizing the [pre-market approval] supplement or [certification] mark," Dave Hickey, president of Integrated Diagnostic Solutions at BD, said in a statement. "Our goal is to continue the global fight towards eliminating diseases and associated deaths due to cervical cancer with our comprehensive diagnostic solutions."

This assay is currently approved for use in patients who have been vaccinated. The screening population will eventually include women with reduced prevalence of HPV 16 and 18 as the previously vaccinated subpopulation ages. This will increase the value of extended genotype reporting in the population of patients who are vaccinated and unvaccinated.

Reference:

BD receives FDA approval for HPV test with extended genotyping capabilities [press release]. PR Newswire. Published July 22, 2020. Accessed July 24, 2020. https://prn.to/2OUzzf6