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Better Hep C Test to Guide Therapy Is Approved

March 8, 2013

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The FDA has approved Roche’s next generation Hepatitis C test that both detects and quantifies the virus.

Roche Gets FDA Approval For Hepatitis-C Therapy Response

Published March 06, 2013 | Dow Jones Newswires

Roche Holding AG (ROG.VX) Wednesday said has received approval from the U.S. Food and Drug Administration for a next-generation viral load test to be used in the management of patients with chronic hepatitis C virus (HCV) infection.

MAIN FACTS:

  • The COBAS AmpliPrep/COBAS TaqMan HCV Test, v2.0 provides a novel dual-probe approach, for an extra layer of protection in detecting and quantifying the virus.
  • The test is designed to accurately determine the amount of hepatitis C virus ribonucleic acid (RNA) in order to assess a patient’s response to antiviral therapy.

Continue reading this entire article:
http://www.foxbusiness.com/news/2013/03/06/roche-gets-fda-approval-for-hepatitis-c-therapy-response/

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