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

Quick Facts

Editors Pick
Fortune has once again named Google Inc. (GOOG, GOOGL) as the best company to work for, with Twitter Inc. (TWTR) also joining the annual list for the first time. This is for the sixth time and for the fourth consecutive time that Google has ranked No.1 in the Fortune's annual list of "100 Best Companies... Dunkin' Donuts has agreed to remove a whitening agent called titanium dioxide, commonly a source of nanomaterials, from all powdered sugar used in its donuts. The move follows pressure from advocacy group As You Sow, which put a shareholder proposal asking Dunkin' to reduce the risks of using nanomaterials in its food products. Warren Buffett's Berkshire Hathaway is reportedly planning its first ever European bond sale of 3 billion euros to take advantage of low interest rates in the region, traversing a path taken by a range of home companies in search of cheap funding options. The move comes as the European Central Bank's bond-buying stimulus program of 60 billion euros a month is imminent.
comments powered by Disqus
Follow RTT