The FDA on Tuesday granted premarket approval to BD's Onclarity HPV Assay.
Here are three things to know.
1. The test, performed on the BD Viper LT system, can detect 14 types of HPV from patient specimens collected for cervical cancer screening or from a Pap smear.
2. The assay can also pinpoint HPV genotypes 16, 18 and 45, which are linked to a majority of cervical cancers.
3. In the future, BD hopes to achieve additional regulatory approvals to use the assay on other HPV types.