BD (Becton, Dickinson and Company), Franklin Lakes, NJ, received a premarket approval (PMA) supplement in the FDA for an Enlarged version of its BD Onclarity human papillomavirus (HPV) assay.
The PMA supplement comprises the expansion for genotype reporting past HPV genotypes 16, 18, and 45 to comprise types 31, 51, 52, 33/58, 35/39/68, and 56/59/66, making the BD Onclarity HPV Assay the only FDA-approved assay to individually identify and report these genotype outcomes.
The worth of elongated genotyping for cervical cancer screening and triage was reported from large clinical trials since 2015. Additionally, the need for expanded HPV genotyping for cervical screening was recognized since 2016. Oftentimes, the coverage of HPV genotypes with all the screening test result could improve risk stratification and support risk-based patient management. The April 2020 book of this ASCCP risk-based management consensus guidelines expected that extended genotyping will be introduced soon.

"BD Onclarity extended genotyping is data-driven precision medication at its best, helping us effectively and efficiently manage our patients," says Mark H. Stoler, MD, professor emeritus of pathology, University of Virginia Health System. "Contemporary management of women with abnormal cervical cancer screening outcomes necessitates an evaluation of their threat of precancer. Plenty of recent science clearly demonstrates that knowing the HPV genotype of the patient offers excellent differential stratification of these risks."

"It is well known that different HPV genotypes carry distinct risk of cervical cancer, and with no particular understanding of the HPV genotype in a screening sample most girls will be over-treated needlessly," says Jesper Bonde, PhD, senior researcher and molecular pathology lab manager, Hvidovre Hospital, Denmark. "Screening strategies that use HPV tests with simultaneous genotyping offer a easy way to improve cervical cancer screening to the benefit of the female and health care providers by enabling risk stratification on the screening sample"

The coverage of HPV genotypes together with all the screening evaluations and surveillance tests will facilitate same-genotype persistence monitoring and risk-based management. A new systematic review by Bottari et al concluded that,"analysis of the HPV genotype persistence may signify a legitimate option to monitor patients treated for CIN 2lesions, since relapses were detected only in patients with persistence of the exact same genotype detected at baseline."

"With this FDA approval, BD can now offer labs, clinicians and patients access to crucial information in screening for cervical cancer in the USA and other nations recognizing the PMA supplement or CE mark," states Dave Hickey, president, integrated diagnostic alternatives at BD. "Our purpose is to continue the global fight towards eliminating diseases and associated deaths due to cervical cancer with our comprehensive diagnostic alternatives."

For more information, visit <span style="color: #ff6600;"><a style="color: #ff6600;" href="https://www.bd.com/en-us">BD</a>.</span>