The cobas HPV Test is the only FDA and CE-IVD approved screening test available in the UK and globally, that individually identifies genotypes 16 and 18, while simultaneously detecting 12 other high-risk HPV genotypes. For laboratory professionals, the test also offers maximum ease of use, reliability and flexibility.
In a separate study published online by the Journal of Clinical Microbiology, a team of Dutch HPV experts led by Danielle Heideman, PhD, clinically validated the cobas 4800 System and the cobas HPV Test for use in primary screening for cervical cancer. The Netherlands was one of the first European nations to announce its intention to use HPV testing as a primary screen for cervical cancer.
Paul Eros, Director of Molecular Diagnostics at Roche in the UK said "Women across England who have abnormal or borderline cervical screen test results will now benefit from an innovation like the cobas HPV Test which improves diagnosis of cervical pre-cancer. It is also particularly encouraging to see the results of the ATHENA sub-analysis and the Dutch study which demonstrate the validity of the cobas® HPV Test for primary screening." Introducing HPV testing at the primary screening stage in England and all parts of the UK would provide an even earlier opportunity to identify women at most risk of cervical cancer before the disease has developed."
About the Roche ATHENA Clinical Trial
The Roche ATHENA study for the cobas HPV Test is the largest U.S.-based registration study for cervical cancer screening, including more than 47,000 women. The study is designed to answer current medical and scientific questions about the importance of testing for high-risk HPV genotypes in cervical cancer screening and to provide clinical information about the specific HPV genotypes that place women at highest risk for developing c
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