The U.S. Food and Drug Administration (FDA) has approved a new test to determine the specific genotype of hepatitis C virus (HCV) an individual is carrying, MedPage Today reports. Called the Abbott RealTime HCV Genotype II, it can differentiate between genotypes 1, 1a, 1b, 2, 3, 4 and 5 with a sample of blood plasma or serum. Previously, genotype tests have been conducted through an only somewhat regulated process in which individual laboratories come up with their own individual screening methods.

Because different genotypes of the virus react differently to therapy, determining genotype can be instrumental to ensuring the best outcome of drug treatment.

The FDA based its approval of the new screening mechanism in part by comparing its accuracy with that of a proven method of gene sequencing. The agency also reviewed data from researchers that looked at the relationship between hep C genotype and treatment outcomes.


To read the FDA release, click here.

To read the MedPage Today story, click here.