The US Food and Drug Administration has granted Becton, Dickinson, and Company (BD) 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 (“Pap test”) in the BD SurePath liquid-based cytology vial,” according to a press release
. In addition, the test can also identify HPV genotypes 16, 18, and 45—genotypes that have been associated with the majority of cervical cancers on a global scale.
In fact, according to the World Health Organization (WHO), HPV genotypes 16 and 18
are responsible for a staggering 70% of cervical cancers and precancerous cervical lesions. HPV genotypes 16, 18, and 45 are “disproportionately responsible” for up to 94% of glandular cervical cancer cases, according to the press release.
The company submitted
the pre-market approval application to the FDA in September 2016 for the HPV assay, which is performed on the BD Viper LT system, a molecular platform which “automates sample processing.” The platform has received previous clearance from the FDA for testing other sexually transmitted diseases, such as chlamydia and/or gonorrhea.
“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,” Dr. Thomas C. Wright, Jr., professor emeritus of pathology and cell biology at Columbia University commented 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.”
The new HPV assay should be used in accordance with clinical guidelines for the screening and management of cervical cancer to detect and identify high-risk HPV genotypes. The test has been clinically validated to be used as a primary screening test “for triaging patients” whose Pap test results come back as abnormal; it can also be used in combination with a Pap test. The information, combined with a physician’s assessment can inform clinical decision-making.
The FDA based their decision on data that was collected during a prospective, multicenter clinical trial that had been carried out in the United States for the duration of several years; the trial included over 33,500 vaccinated and non-vaccinated women.
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