tebkrg
04-20-2003, 09:20 AM
Subject: FDA Approves Test to Measure Hepatitis C Virus RNA
Date: Tue, 8 Apr 2003 16:15:59 -0400
FDA Approves Test to Measure Hepatitis C Virus RNA
Bayer HealthCare has received approval from the U.S. Food and Drug
Administration (FDA) to market its Versant test that directly
measures hepatitis C virus RNA in serum or plasma.
The test is the first and only FDA-approved test to measure HCV
viral load levels. The level of viral load, or HCV RNA, in a
patient's blood can identify patients early in treatment who may
not respond to further therapy.
This can help clinicians decide if therapy should be discontinued,
thereby avoiding the unnecessary side effects of prolonged
treatment.
The National Institutes of Health (NIH) has recommended that HCV
RNA levels be tested as a routine part of monitoring patients with
genotype I hepatitis C. According to NIH, patients who fail to
achieve an early viral response by the 12th week of treatment have
only a small chance of achieving a sustained viral response even
if therapy is continued for a full year.
The test is already being marketed in most of the world, including
Canada and Europe, according to Bayer.
Date: Tue, 8 Apr 2003 16:15:59 -0400
FDA Approves Test to Measure Hepatitis C Virus RNA
Bayer HealthCare has received approval from the U.S. Food and Drug
Administration (FDA) to market its Versant test that directly
measures hepatitis C virus RNA in serum or plasma.
The test is the first and only FDA-approved test to measure HCV
viral load levels. The level of viral load, or HCV RNA, in a
patient's blood can identify patients early in treatment who may
not respond to further therapy.
This can help clinicians decide if therapy should be discontinued,
thereby avoiding the unnecessary side effects of prolonged
treatment.
The National Institutes of Health (NIH) has recommended that HCV
RNA levels be tested as a routine part of monitoring patients with
genotype I hepatitis C. According to NIH, patients who fail to
achieve an early viral response by the 12th week of treatment have
only a small chance of achieving a sustained viral response even
if therapy is continued for a full year.
The test is already being marketed in most of the world, including
Canada and Europe, according to Bayer.