Tuesday, 26 May 2020


Roche cancer test gets expanded CE mark

27 November 2012 | News | By BioSpectrum Bureau

Roche cobas 4800 HPV test for cervical cancer gets expanded CE mark indication

Roche cobas 4800 HPV test for cervical cancer gets expanded CE mark indication

Singapore: Roche has received an expanded CE mark indication for the cobas 4800 human papillomavirus virus (HPV) test as a primary screen. This means that Pap cytology is no longer required as a 'co' or 'pre'-test in countries that accept a CE mark.

Persistent infection with human papillomavirus is the principal cause of cervical cancer in women. The expanded indication is supported by data, which will be presented at the International Papillomavirus Conference, during November 30-to-December 6, 2012, in San Juan, Puerto Rico.

The cobas 4800 HPV test is the only clinically validated, and FDA-approved test, that simultaneously provides pooled results on known high-risk genotypes and individual results on the highest-risk genotypes, HPV 16 and HPV 18, giving three results in just one test. The cobas 4800 HPV Test has a fully automated sample preparation workflow process, and unique efficiency features allowing for higher throughput, making it well suited for high volume screening programs.

Dr Eduardo Franco, director, division of cancer epidemiology, McGill University, Montreal, Canada, said that, "The prevalence of HPV means that many women may test positive, so it is important to also identify those most-at-risk to progress to cervical cancer. The two HPV genotypes, 16 and 18, account for 70 percent of cervical cancer cases."

Dr Paul Brown, head, Roche Molecular Diagnostics, said that, "Switching towards use of the cobas 4800 HPV test as a first line screen enables countries to implement strategies that catch more disease with fewer medical interventions, allows physicians to better manage their patients, and reduces economic costs to the healthcare system."


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