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BD Receives FDA Supplemental Premarket Approval for Extended Genotyping HPV MDx

NEW YORK – Becton Dickinson announced Wednesday that the US Food and Drug Administration has issued a premarket approval supplement for its expanded human papillomavirus assay. The BD Onclarity HPV Assay is now the only FDA-approved test to individually identify and report genotype results in addition to the standard high-risk genotypes 16, 18, and 45, the firm said in a statement.

The test initially received PMA in 2018, and the PMA supplement was submitted to FDA last year. The supplement includes expansion to report the HPV genotypes types 31, 51, 52, 33/58, 35/39/68, and 56/59/66.

The expanded BD Onclarity HPV Assay now detects and identifies 14 high-risk HPV types in a single analysis and provides genotyping information, BD said. It uses specimens collected for cervical cancer screening purposes in the BD SurePath Collection Vial and is authorized outside the US for use with samples collected in Hologic PreservCyt Solution.

"With this FDA approval, BD can now offer laboratories, clinicians and patients access to critical information in screening for cervical cancer in the US and other countries recognizing the PMA supplement or CE mark," Dave Hickey, president of integrated diagnostic solutions at BD, said in a statement.

Different HPV genotypes carry different risk of cervical cancer, and genotyping could reduce overtreatment. BD also noted that reporting of HPV genotypes with screening and surveillance testing could facilitate tracking of same-genotype persistence, as such persistence has been correlated to relapse in patients with a certain class of cervical lesion.

A number of clinical studies have reported that extended genotyping has benefits for cervical cancer screening and triage, particularly for risk stratification and risk-based patient management. An article published earlier this year regarding the American Society for Colposcopy and Cervical Pathology risk-based management consensus guidelines anticipated that extended genotyping will be introduced soon, BD noted. 

The BD test has FDA approval for clinical use in cytology-based screening with ASC-US triage, in a co-testing paradigm, and in primary HPV screening. It also has FDA approval for use in vaccinated women, who are likely to show reduced prevalence of HPV 16 and 18, "increasing the value of extended genotype reporting in a mixed population of vaccinated and unvaccinated women," BD noted.