www.fdanews.com/articles/202761-becton-dickinsons-self-collection-hpv-test-receives-ce-mark
Becton Dickinson’s Self-Collection HPV Test Receives CE Mark
May 14, 2021
Becton Dickinson has received CE mark certification for its Onclarity HPV Assay, a human papillomavirus test that can also help screen for cervical cancer.
Using the assay, women can collect vaginal samples at home and send them to a laboratory for processing on the company’s Viper LT or COR systems.
The assay identifies 14 high-risk forms of HPV in a single analysis and provides genotyping information from specimens for use in cervical cancer screening.