FDA grants premarket approval for HPV test

The Onclarity HPV assay received premarket approval from the FDA, according to manufacturer Becton, Dickinson and Company.

The test singles out HPV genotypes 16, 18, and 45 and, when used with the company’s liquid-based cytology vial, locates 14 types of high-risk HPV from specimens that are collected during screening for cervical cancer, the company said in a press release. The genotypes are linked to the majority of cervical cancers worldwide and are “disproportionally responsible” for as many as 94% of glandular cervical cancer cases, according to the release.

“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, Becton, Dickinson and Company (BD) Diagnostics Systems, said in the release. “The addition of the BD Onclarity HPV assay to BD’s women’s health and cancer portfolio will enable BD to continue to enhance the standard of patient care, representing the next milestone in cervical cancer screening.”

The assay is “clinically validated” as the first screening test for triaging patients with abnormal Pap test results and should be utilized in conjunction with such tests, according to the release.

The assay is in line with clinical screening guidelines from the American Cancer Society, the American Society for Clinical Pathology American Society for Colposcopy and Cervical Pathology, according to the press release.

BD also said the FDA reviewed data collected during a multi-year, prospective, multi-center clinical U.S.-based trial conducted involving more than 33,500 vaccinated and nonvaccinated women before making its decision. The test is already available in Japan, Canada and parts of Europe, according to the release.

Disclosure: Hickey works for Becton, Dickinson and Company.