Roche announced that the FDA has approved the cobas HPV Test, which is now available, to identify women at highest risk of developing cervical cancer. The cobas HPV Test is a qualitative in-vitro test for the detection of HPV in patient specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk HPV types in a single analysis. The test specifically identifies HPV genotypes 16 and 18 while concurrently detecting the other high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68).
The approval of the cobas HPV Test was based on data from the ATHENA study involving more than 47,000 women in the U.S. Results demonstrated that 1 in 10 women ≥30 years that tested positive for HPV 16 and/or 18 by the cobas HPV Test had cervical pre-cancer, though they showed normal results with the Pap test.
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