New research points to benefits of innovative cobas® HPV test for primary screening as England's cervical cancer screening programme includes the test in current HPV "triage" rollout

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Nov 17, 2011, 09:00 ET

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® 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® 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 cervical cancer. Results show the cobas HPV Test is comparable to the current standard of testing. Results also demonstrated that one in 10 women, age 30-years and older, who tested positive for HPV 16 and/or 18 by the cobas HPV Test had cervical pre-cancer, although their Pap test was normal.

About the cobas HPV Test on the cobas 4800 platform

Roche's cobas HPV Test simultaneously detects 12 high-risk HPV types (HPV types 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) as a pooled result, as well as HPV genotypes 16 and 18 individually. Roche received FDA approval on the cobas HPV Test and in April 2011 and launched the cobas HPV Test in countries that accept CE Mark in 2009.

Due to key features such as the "load and go" facility for reagents, The cobas HPV test is easy and simple to use with minimal hands-on and maximum walkaway time whilst providing high throughput capabilities and has the flexibility to meet smaller throughput requirements.

About Human Papillomavirus and Cervical Cancer

Persistent infection with human papillomavirus is the cause of cervical cancer in women, with HPV being found in 99.7 per cent of cervical cancers worldwide. Of the more than 118 different types of HPV, the cobas® HPV Test identifies the 14 high-risk types associated with the development of cervical cancer and its precursor lesions. HPV types 16 and 18 have been identified as the highest risk genotypes, detected in approximately 70 per cent of cervical cancers. Nucleic acid (DNA) testing is a sensitive and non-invasive method for determining the presence of HPV infection.

The World Health Organization estimates there are 470,000 new cases of cervical cancer annually.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2010, Roche had over 80,000 employees worldwide and invested over 9 billion Swiss francs in R&D. The Group posted sales of 47.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: http://www.roche.com and http://www.roche.co.uk.

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SOURCE Roche