According to an investigation recently published online in The Lancet Oncology, data from a sub-analysis of the Addressing THE Need for Advanced HPV Diagnostics (ATHENA) landmark study, showed that the HPV test Roche cobas, may be used for initial screening of cervical cancer.

Furthermore, data from the study demonstrated that vital predictive information in determining a woman’s risk of cervical cancer was provided by identifying women with HPV 16 and/or 18 (the two genotypes identified in around 70% of cervical cancers).

Cytology testing (Pap test) is allowed in order to determine the risk of cervical cancer by current cervical cancer screening guidelines. However, according to data, cervical cancer was identified at a higher rate using HPV DNA testing as primary (first-line) screening than cytology alone. These results suggest that HPV testing for pooled high risk HPV with simultaneous HPV 16/18 genotyping, may offer a more effective and sensitive approach for cervical cancer screening.

Mark H. Stoler, MD, Professor and Associate Director of Surgical Pathology and Cytopathology at the University of Virginia Health System, explained:

“The ATHENA study continues to provide ample data to help refine and advance HPV screening. 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 individually detects HPV 16 and 18, while at the same time identifying 12 addition high-risk HPV genotypes. The test is the only FDA and CE-IVD approved screening test available in the UK and globally. In addition, the test also provides reliability, maximum ease of use, as well as flexibility for laboratory professionals.

In an independent investigation published online by the Journal of Clinical Microbiology, the cobas HPV Test and the cobas 4800 System were clinically validated for use in primary screening for cervical cancer by a team of experts from the Netherlands led by Daniella Heideman, P.h.D. The Netherlands was one of the first countries in Europe 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, explained:

“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 part of the UK would provide an even earlier opportunity to identify women at most risk of cervical cancer before the disease has developed.”

Written by Grace Rattue