logo
Share SHARE
FONT-SIZE Plus   Neg

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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
American Airlines Group said pilots at its subsidiaries American Airlines and US Airways, represented by Allied Pilots Association, have approved a new five-year contract which provides immediate pay raises of 23 percent and subsequent annual raises of three percent for the next five years. LEGO Group, TT Games and Warner Bros. Interactive Entertainment have announced their 2015 slate of video games, including LEGO Jurassic World, LEGO Marvel's Avengers, and as well as new hand-held and mobile titles. Social-networking giant Facebook, Inc. is said to be testing their new 'Place Tips' feature for iOS users that will rival a similar service being provided by Yelp or Foursquare. The feature will provide the user relevant content about their location as long as they are there through pop ups on their news feed page of Facebook.
comments powered by Disqus
Follow RTT