Roche (RHHBY) Announces Receipt of FDA Approval for cobas MPX Test
- 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 daily under-the-radar research with StreetInsider.com's Stealth Growth Insider Get your 2-Wk Free Trial here.
Roche (OTC: RHHBY) announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the cobas MPX test for use on the cobas® 6800 and 8800 Systems. The cobas MPX test enables donor screening laboratories to apply the most advanced PCR-based diagnostic technology to the surveillance of donated blood and plasma in the United States, preventing the spread of Human Immunodeficiency Virus Groups 1 and 2 (HIV-1 and HIV-2), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) through transfused blood products.
"This approval reinforces our strong presence in donor screening, and underscores our ability to provide proven, robust technology for the testing of donated blood and blood products," said Uwe Oberlaender, Head of Roche Molecular Diagnostics. "We will continue to partner with donor screening laboratories worldwide demonstrating our joint commitment to patient safety."
The fully automated cobas 6800/8800 Systems offer the fastest time to results, the highest throughput and the longest walk-away time available among automated molecular platforms, providing blood and plasma screening laboratories with improved operating efficiency and flexibility to adapt to changing testing demands. Earlier this year, Roche initiated testing for Zika virus at U.S. blood centers under FDA Investigational New Drug Application protocol with the cobas® Zika test for use with the cobas® 6800/8800 Systems.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Biogen (BIIB), AbbVie (ABBV) Receive Health Canada Approve for Once-Monthly Zinbryata
- Valeant Pharma (VRX) Announces Positive Results from IDP-118 Phase 3 as Psoriasis Treatment
- Cellular Biomedicine Group (CBMG) AlloJoin AE from Phase I Similar to Prior Autologous Trial
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!