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FDA Approves New Workflow Option for Roche's Cobas HPV Test

NEW YORK (GenomeWeb News) – Roche today said that the US Food and Drug Administration approved a new workflow process for the company's Cobas HPV test.

The newly approved workflow option allows for a sample to be processed from the primary sample collection vial directly after it has been used for cytology testing. This allows laboratories to load the same vial used for a ThinPrep Pap test onto the Cobas 4800 system for high-risk human papillomavirus and individual HPV 16 and HPV 18 genotype testing, Roche said.

The option uses a special primary vial rack for the Cobas 4800 instrument and eliminates the need for lab technicians to pipette samples from the primary vials used for liquid-based cytology into another tube. Allowing the same vial to be loaded on the Cobas 4800 directly after cytology processing, reduces costs, shortens the turnaround time, and frees lab staff to perform other tasks, Roche said.

The Cobas HPV test, cleared by FDA in 2011, is the first HPV test approved by FDA for loading a Pap sample directly onto an automated platform and for the use of primary vial samples after cytology processing on either the ThinPrep 3000 or ThinPrep 2000 system.

"With new clinical guidelines for cervical cancer screening issued last year, the demand for HPV co-testing has the potential to increase significantly," Alan Wright, CMO for Roche Diagnostics, said in a statement. "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."