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

Editors Pick
After moving modestly higher in morning trading, stocks showed a substantial move to the downside over the course of the trading day on Wednesday. The major averages pulled back well off their highs for the session, sliding firmly into negative territory. Ebola "czar" Ron Kain is scheduled to meet with President Barack Obama on Wednesday as he begins his efforts to coordinate the government's response to the deadly disease. Klain, who previously served as chief of staff to Vice President Joe Biden and then-Vice President Al Gore, was named as Ebola Response Coordinator last Friday. Potentially complicating the outlook for control of the Senate, the results of a SurveyUSA poll conducted for WXIA-TV in Atlanta suggest that the Georgia Senate race between Republican David Perdue and Democrat Michelle Nunn could be headed for a runoff.
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.