Roche's (RHHBY) Expanded Label for cobas EGFR Mutation Test v2 Receives FDA Approval
- Record-setting rally pushes on as S&P ends week up 3 percent
- Trump's Cohn Pick Most Bullish Sign Yet for Banks - Cowen
- Unusual 11 Mid-Day Movers: (IDXG) (INVN) (EBS) Higher; (SCON) (DTEA) (DLTH) Lower (more...)
- 21st Century Fox (FOXA) offers to acquire Sky for GBP10.75/share
- Coca Cola (KO) Announces James Quincey to Succeed Muhtar Kent as CEO; Kent to Continue as Chairman
Get access to the best calls on Wall Street with StreetInsider.com's Ratings Insider Elite. Get your Free Trial here.
Roche (OTC, RHHBY) announced that the U.S. Food and Drug Administration (FDA) has approved a label extension of the cobas EGFR Mutation Test v2 for use with plasma samples as a companion diagnostic for Astra Zeneca's non-small cell lung cancer (NSCLC) therapy TAGRISSO™ (osimertinib).
"The label extension for the cobas® EGFR Mutation Test v2 to include another TKI (tyrosine-kinase inhibitor) therapy shows our continued commitment to helping healthcare providers make the best diagnosis for their NSCLC patients at multiple stages of their treatment pathway," said Uwe Oberlaender, Head of Roche Molecular Diagnostics.
On June 1st, 2016, the FDA granted approval of the cobas® EGFR Mutation Test v2, making it the first FDA-approved liquid biopsy test for use in clinical decisions. The test is the only companion diagnostic that is FDA-approved for the detection of the epidermal growth factor receptor (EGFR) gene in DNA derived from plasma or tumor tissue. NSCLC patients who have EGFR exon 19 deletions or L858R mutations are candidates for the EGFR-targeted therapy Tarceva® (erlotinib), in first-line treatment, and patients who have the resistance mutation T790M are candidates for TAGRISSO™ in subsequent lines of treatment.
Current clinical guidelines, including those from the National Comprehensive Cancer Network (NCCN) in the U.S., and the European Society for Medical Oncology (ESMO), recommend EGFR mutation testing in patients with advanced NSCLC, prior to administering targeted therapies.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Genomic Health (GHDX) Reports Results from Multiple Oncotype DX Studies
- Dynegy (DYN) Subsidiary Genco Files for Court Approval of Prepackaged Reorganization Plan
- Whirlpool (WHR) Announces U.S. Confirms Samsung and LG Dumped Washers
Create E-mail Alert Related CategoriesCorporate News, FDA, Management Comments
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!