FDA Approves Cervical Cancer-Related–HPV Test

The FDA has approved a new test for the Human Papilloma Virus (HPV) which can detect the genotypes likely to cause cervical cancer in women.

The Onclarity™ HPV Assay is capable of detecting 14 HPV types. Developed by BD, this test can identify HPV genotypes 16, 18, and 45—which are associated with the majority of cervical cancer cases and 94% of glandular cervical cancer cases. It utilizes the BD SurePath liquid biopsy cytology vial during a cervical cancer screening (“Pap test”).

The assay is performed on a BD Viper™ LT system, which is a benchtop molecular platform that automates sample processing. The Viper LT system is also FDA-approved for testing for chlamydia and gonorrhea infection.

During the FDA evaluation, they reviewed data on more then 33,500 vaccinated and non-vaccinated women at multiple centers in the U.S. The test is clinically validated for use as a primary ...