Hepatitis C is one of the most common blood-borne infections in the world. Often called the “silent killer”, Hep C infects about 3.2 million people in the U.S and kills 15,000 people annually. It commonly leads to liver failure, is the leading indication for liver transplants — and the problem is that no vaccine exists for it.
Certain genotypes of HCV — namely 1 and 1a — are harder to treat and more aggressive than others, such as genotypes 2 through 5. Utilizing the differential susceptibilities of different genotypes, a new diagnostic test called the Abbott RealTime HCV Genotype II, developed by Abbott Molecular, was approved by the Food and Drug Administration. For the first time, a diagnostic test will allow doctors to determine what kind of hepatitis C virus a chronically infected patient has, and tailor treatments based on that genetic type.
According to a press release,
Ten years after the complete sequencing of the human genome, the approval demonstrates the growing use of individual molecular analysis to diagnose and treat diseases, said Edward Abrahams, president for the Personalized Medicine Coalition.
“It’s where medicine is headed,” he said.
In addition to avoiding the side effects of ill-fitted drug therapies, linking treatment with genotyping tests can “reduce costs, as we won’t have to prescribe one-size-fits-all treatment to all-comers,” he added.
Clinical research has shown that use of the RealTime HCV Genotype II reduces total assay time from 10.5 to 6.0 hours and hands-on time from 13 to 4 minutes per patient sample compared to previous diagnostics such as the Versant LiPA on the AutoBlot 3000 (Siemens Healthcare Diagnostics). These are encouraging results for practitioners and researchers of this intractable disease.
Product page: RealTime HCV Genotype II…