What are the FDA-approved indications for the human papillomavirus (HPV) DNA test?

Updated: Feb 20, 2020
  • Author: Peter A Gearhart, MD; Chief Editor: Pranatharthi Haran Chandrasekar, MBBS, MD  more...
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The US Food and Drug Administration (FDA) has approved an expanded indication for an HPV DNA test, making it the first such test that can be used alone for primary cervical cancer screening in women aged 25 years or older. The test, the cobas HPV Test, detects DNA from 14 high-risk HPV types in cervical cell samples. A positive test for HPV type 16 or 18 is considered an indication for a colposcopy; a positive test for any of the 12 other high-risk HPV types is considered an indication for a Papanicolaou (Pap) test, in order to determine the need for colposcopy. The cobas HPV Test was first approved in 2011 for use in conjunction with or as a follow-up to a Pap test. [64]

Research supporting the expanded indication included a study of more than 40,000 women aged 25 years or older. The women underwent routine cervical exams, with a colposcopy and cervical tissue biopsy performed on those who had a positive Pap test or whose cervical cells screened positive for HPV, as well as on a subset of women with negative Pap and HPV tests. Comparison of the biopsy results with those from the Pap and cobas HPV tests showed that the HPV test would be effective even when used alone. [64]

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