LONDON, November 17, 2011 /PRNewswire/ --
As the new cobas HPV test from Roche is accepted for the national cervical cancer screening programme in England for use at triage, further research also supports the use of Roche's cobas HPV test in "primary" screening as part of a more sensitive and more efficient strategy in the fight against cervical cancer
Data from a sub-analysis of the ATHENA (Addressing THE Need for Advanced HPV Diagnostics) landmark study, recently published online in The Lancet Oncology, demonstrated that the Roche cobas HPV Test, could be used for the primary screening of cervical cancer. The data also showed that identifying women with HPV 16 and/or 18, the two genotypes detected in approximately 70 per cent of cervical cancers, provided important predictive information to determine a woman's risk of cervical disease.
Current guidelines for cervical cancer screening allow for cytology testing (Pap test) to determine the risk of cervical cancer. However, data demonstrated that HPV DNA testing as primary (first-line) screening identified cervical disease at a higher rate than cytology alone. These results indicate that HPV testing for pooled high risk HPV with simultaneous HPV 16 and HPV 18 genotyping, could provide a more sensitive and more efficient strategy for cervical cancer screening. "The ATHENA study continues to provide ample data to help refine and advance HPV screening," said Mark H. Stoler, MD, Professor and Associate Director of Surgical Pathology and Cytopathology at the University of Virginia Health System. "These new data suggest that HPV testing is an efficient, reliable and potentially cost-effective primary screening tool. Moreover, the use of the HPV 16 and 18 genotyping information provided by the cobas(R) HPV Test or reflex cytology, would offer a rational approach for determining which HPV positive women need immediate follow up."
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(R) 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."