GNMK misses the bus again....beaten by a competitor again
"FDA approves first genotyping test for patients with hepatitis C virus
The U.S. Food and Drug Administration today approved a test that identifies the genotypeof hepatitis C virus (HCV) that apatientis carrying. The Abbott RealTime HCV Genotype II, which can differentiate genotypes 1, 1a, 1b, 2, 3, 4, and 5,using a sample of an infected patient’s blood plasma or serum, will aid health care professionals in determining the appropriate approach to treatment. Because the various HCV genotypes respond differently to available drug therapies, knowing the type of HCV a person is infected with can result in better patient outcomes.
“Tests such as this one can help physicians gain an understanding of a patient’s HCV status,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health. “Along with other clinical factors, the particular type of HCV is an important consideration in aiding health care professionals in determining if and when to initiate treatment and the appropriate type of treatment.”
The Abbott RealTime HCV Genotype II is approved for individuals known to be chronically infected with HCV. It is not approved for use as a diagnostic test or as a screening test for the presence of HCV genetic material in blood, blood products or tissue donors. It has not been evaluated in newborns or pediatric patients, or in patients with compromised immune systems, such as people with AIDS.
The FDA based its approval of the Abbott RealTime HCV Genotype II, in part, on the assessment of the test's accuracy in differentiating specific HCV viral genotypes compared to a validated genesequencing method. The FDA also reviewed data from investigators demonstrating the relationship between HCV genotype and effectiveness of drug therapy."
ABT beat them thru the FDA and ABT also has an approved HCV viral load test.