Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

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

Swiss pharmaceutical giant Roche Holding AG (RHHBY.PK) Wednesday said the US Food and Drug Administration has approved a new workflow process for the cobas HPV Test, allowing sample processing from the primary sample collection vial after it has been used for cytology 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.

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 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.

Click here to receive FREE breaking news email alerts for Roche Holding AG and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
After turning in a mixed performance last week, stocks may continue to experience choppy trading early on Monday. The major index futures are currently pointing to a roughly flat open for the markets, with the Dow futures up by just 2 points. President Barack Obama is meeting with presidents from Central American nations on Friday as the U.S. struggles to deal with a surge of unaccompanied children across the southern border. Despite calls from some leading conservatives, the results of a new CNN/ORC International poll released Friday showed that a vast majority of Americans do not believe that President Barack Obama should be impeached and removed from office.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.