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FDA Actions & Updates

The latest approvals, designations, and new indications from the U.S. Food and Drug Administration for oncology drugs.

Tuesday, February 13, 2018

New Assay Approved to Detect & Identify HPV Genotypes Linked to Increase Risk of Cervical Cancer

The FDA has granted pre-market approval for the BD Onclarity HPV assay. The test detects 14 types of high-risk human papillomavirus (HPV) from specimens collected for cervical cancer screening in the BD SurePath liquid based cytology vial.

The assay also identifies HPV genotypes 16, 18, and 45, which are associated with the majority of cervical cancers worldwide, and are disproportionally responsible for up to 94 percent of glandular cervical cancer cases. In evaluating the test, the FDA reviewed data collected during a multi-year, prospective, multi-center clinical trial conducted in the U.S. that included more than 33,500 vaccinated and non-vaccinated women.

It may be used in accordance with clinical guidelines for cervical cancer screening and management to identify the presence of high-risk HPV types. The test is clinically 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 assay provides information that together with the physician's assessment and professional guidelines, may be used to inform clinical decision-making.  

"The approval of the [HPV assay] provides clinicians and laboratories an FDA-approved option for HPV primary screening with the liquid based cytology vial," noted Thomas C. Wright, Jr., MD, Professor Emeritus of Pathology and Cell Biology at Columbia University. "The BD Onclarity HPV assay also aligns with clinical screening guidelines from the American Cancer Society, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology."

The assay is performed on the BD Viper LT system, a bench top molecular platform which automates sample processing and is also FDA-cleared for chlamydia and/or gonorrhea infection testing.