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Roche's new workflow option for cobas HPV Test receives FDA approval

PBR Staff Writer Published 27 June 2013

The US Food and Drug Administration (FDA) has approved Roche's new streamlined workflow process for the cobas Human Papillomavirus (HPV) Test, which help labs reduce costs, improve turnaround time and focus on other key tasks.

Roche Diagnostics chief medical officer Dr Alan Wright said the demand for HPV co-testing has the potential to increase significantly after the new clinical guidelines for cervical cancer screening was issued in 2012.

"Giving labs the option to use the same primary vial from a Pap test for HPV testing lets them eliminate a complete step in their workflow process and lower the risk of errors in sample handling, helping to ensure that patients receive accurate test results," Wright added.

Using a special primary vial rack, the new workflow option allows the same vial used for a ThinPrep Pap test to load directly onto the fully automated cobas 4800 system for HPV and individual HPV 16 and 18 genotype testing.

Approved by the FDA in 2011, the cobas HPV Test screens patients aged 21 and older with abnormal Pap test results and to co-test with Pap in women ages 30 to 65 to assess the presence or absence of high-risk HPV genotypes.

The test is carried out on the cobas 4800 System, which automatically performs nucleic acid purification, PCR (polymerase chain reaction) set-up and real-time PCR amplification and detection to help laboratories achieve maximum efficiency.