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 “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.
FDA news release