First HPV Test Approved for Primary Cervical Screening

By the Editors

The FDA has approved the first human papillomavirus DNA test for women aged 25 and older that can be used as a stand-alone tool for primary cervical cancer screening.

The so-called cobas HPV Test, which identifies HPV-16, HPV-18, and twelve other high-risk strains, was initially approved in 2011 for use in tandem with, or as a follow-up to, a Pap test.

Patients who test positive for HPV-16 or -18 should undergo a colposcopy, while those who test positive for any of the other high-risk HPVs should undergo a Pap test to determine whether a colposcopy is warranted.