First HPV Test Approved for Primary Cervical Screening

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

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