Assay gains new indication to expand genotype reporting

WASHINGTON — The FDA approved an expanded version of a human papillomavirus (HPV) test (BD Onclarity HPV assay) that can identify additional viral genotypes.

Whereas the assay was previously indicated to recognize and report HPV genotypes 16, 18, and 45, this expansion allows the product to test for genotypes 31, 51, 52, 33/58, 35/39/38, and 56/59/66. To date, this is the only HPV test approved to identify these genotype results.

“The value of extended genotyping for cervical cancer screening and triage has been reported from large clinical studies since 2015,” the product’s manufacturer, BD, wrote in a press release. “Additionally, the need for expanded HPV genotyping for cervical screening has been recognized since 2016. In many cases, the reporting of HPV genotypes with the screening test result could improve risk stratification and support risk-based patient management. The April 2020 publication of the ASCCP risk-based management consensus guidelines anticipated that extended genotyping would be introduced soon.”

In a statement, Jesper Bonde, PhD, senior researcher and molecular pathology laboratory manager at Hvidovre Hospital in Denmark — who published a systematic review assessing the clinical utility of HPV genotyping in cervical cancer screening in January of this year — noted that “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. 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.”

John McKenna, Associate Editor, BreakingMED™

Cat ID: 190

Topic ID: 79,190,730,190,192,725