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 disproportionally responsible for up to 94 percent of glandular cervical cancer cases.
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, New York, N.Y.
The assay is performed on the BD Viper LT system, a benchtop molecular platform that automates sample processing and is FDA-cleared for chlamydia and/or gonorrhea infection testing.