FDA Approves New Streamlined Workflow Option for Roche's Cobas HPV Test
News Jun 28, 2013
Roche has announced 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.
Wright continued, "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.
Diabetic Ketoacidosis Assay Collaboration Between Ortho Clinical Diagnostics and EKF DiagnosticsNews
EKF’s Beta-Hydroxybutyrate LiquiColor® Assay for detection of predominant ketone body now available on Ortho’s VITROS® 4600 Chemistry System and VITROS® 5600 Integrated System.READ MORE
Fabric Genomics Partners to Improve Pediatric CareNews
Partnerships with Genomics England, Rady Children's Institute for Genomic Medicine, and The Utah Genome Project demonstrate diagnostic utility of Fabric Genomics' algorithm-based genome analysis.READ MORE
Key Cancer-Linked Proteins Thought to be ‘Undruggable’ Until NowNews
A new study published in Nature, conducted by an alliance between industry and academia involving the University of Liverpool, highlights a new approach to targeting key cancer-linked proteins, thought to be ‘undruggable’.READ MORE