Cobas HPV test for first-line screening for cervical cancer.

On April 24, 2014, the cobas HPV Test was approved by the US Food and Drug Administration for use as a first-line primary screening tool in women aged 25 years or older to assess risk of cervical cancer based on the presence of clinically relevant high-risk human papillomavirus (HPV) DNA. It is the first and only HPV test indicated as the first-line primary screen for cervical cancer in the United States. The test simultaneously provides pooled results for high-risk (HR) genotypes (HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) and individual results for HPV-16 and HPV-18, the highest-risk genotypes.