FDA Approves Test to Identify Women with Increased Risk for Cervical Cancer

BD Onclarity HPV Assay, a test that can detect up to 14 types of high-risk human papillomavirus (HPV) and provides information on women who are at risk for cervical cancer, received pre-market approval from the Food and Drug Administration (FDA), according to a press release by Betcon, Dickinson and Company, the New Jersey-based manufacturer of the test.

The approval comes from a multi-center prospective clinical trial that included more than 33,500 women — not all of whom had the HPV vaccine.

To use the test, cervical specimens are collected via “Pap test” in the BD SurePath liquid-based cytology vial. The BD Onclarity HPV Assay can then be used to identify HPV genotypes 16, 18 and 45, which are strongly associated with cervical cancers worldwide, and are responsible for about 94 percent of glandular cervical cases, according to research published in Lancet Oncology and the International Journal of Cancer, cited in the press release.

Results of the primary screening test could help to triage patients whose results come up as abnormal. Together with a physician’s assessment, information gathered from the BD Onclarity HPV Assay could be instrumental in clinical decision-making.

“Our goal is to provide laboratories and clinicians worldwide with comprehensive cervical cancer screening solutions that address the unique needs of individual health care providers and patients,” Dave Hickey, president of BD Diagnostics Systems said in the release.

The FDA grants premarket approvals (PMAs) to class 3 medical devices that, through scientific evidence and research, assure that the product is safe and effective in what it is intended to do. Obtaining a PMA grants the product marketing clearance in the United States.

“The approval of the BD Onclarity HPV Assay provides clinicians and laboratories an FDA-approved option for HPV primary screening with the BD SurePath liquid-based cytology vial,” Thomas C. Wright, Jr., professor emeritus of pathology and cell biology at Columbia University said in the release.

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.