Becton Dickinson gains FDA approval for BD Onclarity HPV assay

Becton Dickinson announced Tuesday that it received FDA approval for the BD Onclarity HPV assay, which can detect 14 high-risk human papillomavirus (HPV) types "and provide additional information to guide physician decision-making." Dave Hickey, president of BD Diagnostics Systems, remarked that the approval of the assay represents "the next milestone in cervical cancer screening."

Specifically, the company noted that the assay, which can detect 14 types of high-risk HPV from specimens collected for cervical cancer, can also identify HPV genotypes 16, 18, and 45, which are responsible for "up to 94 percent of glandular cervical cancer cases." 

According to Becton Dickinson, the FDA's approval was based on a review of study data collected from more than 33 500 vaccinated and non-vaccinated women. The test is "validated for use as a primary screening test, for triaging patients with abnormal Pap test results and to be used in combination with a Pap test," the company added.

The BD Onclarity HPV assay received CE-IVD mark in 2014, and gained regulatory approval in Canada and Japan last year. Becton Dickinson said that it plans to seek approval for reporting of further HPV types "consistent with the extended genotyping capabilities of the assay's design and aligned with evolving cervical cancer screening guidelines."

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