The FDA has approved a new test for the human papillomavirus (HPV). The new test, which is called the Onclarity™ HPV assay, can detect the genotypes likely to cause cervical cancer in women.
Developed by BD Diagnostic Systems, the new test can identify 14 HPV genotypes, including HPV types 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 the detection of chlamydia and gonorrhea infection.
During the FDA evaluation, data on more than 33,500 vaccinated and nonvaccinated women at multiple centers in the United States were reviewed. The test is clinically validated for use as a primary screening test, for triaging patients that have abnormal Pap test results, and for use in combination with a Pap test.
“Our goal is to provide laboratories and clinicians worldwide with comprehensive cervical cancer screening solutions that address the unique needs of individual healthcare providers and patients,” said Dave Hickey, president, BD. “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 Onclarity HPV assay received a CE-IVD mark in 2014, gained regulatory approval in Canada and Japan in 2017, and is currently for sale in these markets.