Assay is Commercially Available for Patient Testing and Clinical Trials BURLINGTON, N.C.--(BUSINESS WIRE [1])-- Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH) announced today the nationwide availability of a genetic test to detect the presence of a single polymorphism within the IL-28B gene that has been reported to help predict a person’s response to certain hepatitis C virus (HCV) therapies.
“This test represents an important addition to the management and treatment of HCV infections, and complements the current company test portfolio for this disease,” indicated Dr. Mark Brecher, LabCorp’s Chief Medical Officer. “The ability to detect the polymorphism within the IL-28B gene may help predict the response to treatments, leading to an improvement in patient care and a reduction in treatment costs.”
An estimated 3.2 million people in the United States and 170 million people worldwide are infected with HCV. The recommended treatment regimen for chronic infection includes pegylated interferon-based therapies. However, some patients experience limited efficacy, treatment is often poorly tolerated and the side effects prevent some patients from completing therapy. Therefore, identifying patients who may be likely to have a favorable response to treatment is a high priority.
The importance of the IL-28B genetic polymorphism was first reported in the journal Nature (September 2009) by scientific teams from Merck and Duke University. Specific variants in this gene have been associated with an approximately 2-3 fold greater rate of sustained viral suppression in response to treatment with combination pegylated interferon alfa/ribavirin therapy among patients infected with HCV genotype 1 with a CC genotype as compared with either the CT or TT genotypes. HCV genotype 1 is the most common form of the virus, accounting for approximately 70 percent of HCV cases in the U.S.
The test is now available for patient testing through LabCorp’s Centers of Excellence, Monogram Biosciences and The Center for Molecular Biology and Pathology (CMBP). The test is also available through Esoterix Clinical Trials Services for clinical trials. LabCorp has licensed global rights to this marker from Merck.
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Not sure how I missed this press release from LabCorp issued in late August, but it's an important one. LabCorp has effectively positioned itself early to take advantage of a potential VERY lucrative market. What remains to be seen is how MCO/ACO's embrace this test. From my standpoint, it could give them valuable information about a patient's potential response to STAT-C therapy and could effectively offer significant savings. The ethical attributes of denying STAT-C treatment need to be explored further, however.
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