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Roche on Monday announced that the FDA approved its cobas human papillomavirus (HPV) test for the first-line screening of cervical cancer in women aged 25 years and older using cervical specimens collected in SurePath preservative fluid. The company noted that the test is now the only HPV test approved for primary screening with both SurePath and the ThinPrep PreservCyt solution, "two types of liquid media used to collect samples for the vast majority of Pap or HPV tests in the US."
Ann Costello, who heads Roche Tissue Diagnostics, commented that "before today, laboratories did not have an FDA-approved HPV test available that could cover all of the HPV screening options supported in professional guidelines and be used with both of the primary Pap test collection media." She said the additional approval now gives laboratories and clinicians "an approved option that can be used for all of their HPV screening indications and sample types."
Roche's cobas HPV test first gained FDA approval in 2014 as a first-line cervical cancer screening tool, without an accompanying Pap test. The agency expanded the indication in 2016 to include use with the SurePath cell collection medium commonly used for Pap tests.
The cobas HPV test, clinically validated via the ATHENA study and introduced in 2011, detects the presence of HPV genotypes 16 and 18, and also reports the 12 other high-risk HPV types as a combined result, based on a single patient sample. The test is approved in the US for use with the cobas 4800 system, whose test menu includes chlamydia and gonorrhea, HSV 1 and 2, MRSA/SA and C. difficile, as well as BRAF, EGFR and KRAS mutations.
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