FDA approves new streamlined workflow option for Roche's cobas HPV Test

Roche

announced today that the U.S. Food and Drug Administration (FDA) has approved a new, more efficient workflow process for the cobas HPV Test, allowing sample processing from the primary sample collection vial after it has been used for cytology (Pap) testing. This development allows labs to load the same vial used for a ThinPrep Pap test directly onto Roche's cobas 4800 System for high-risk HPV (Human Papillomavirus) and individual HPV 16 and 18 genotype testing, which is used to help identify women at risk for cervical cancer. "With new clinical guidelines for cervical cancer screening issued last year, the demand for HPV co-testing has the potential to increase significantly," said Alan Wright, MD, MPH, chief medical officer for Roche Diagnostics. "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." The new workflow option utilizes a special primary vial rack for the fully automated cobas 4800 System. The new process eliminates the need for lab technologists to pipette samples from the primary vials used for liquid-based cytology into a separate tube. Instead, they can load the same vial onto the cobas 4800 System directly after cytology processing. The streamlined workflow can help labs reduce costs, improve turnaround time and free staff to spend time on other critical tasks. The cobas HPV Test, approved by the FDA in 2011, is the first HPV test to receive FDA approval for loading a Pap sample vial directly onto an automated system and for the use of primary vial samples after cytology processing on either the ThinPrep 3000 (T3000) system or the ThinPrep 2000 (T2000) system.