Laboratory Corporation of America ® Holdings (LabCorp ®) (NYSE: LH) announced today the immediate availability of an enhanced version of its HCV GenoSure ® NS3/4, a drug resistance test that screens for the Q80K polymorphism. Q80K is a naturally occurring polymorphism that develops in certain strains of HCV, making the virus less susceptible to Janssen Therapeutics’ OLYSIO™ (simeprevir), which was recently approved by the U.S. Food and Drug Administration for the treatment of certain adult patients diagnosed with genotype 1chronic hepatitis C (HCV). In clinical trials, patients with HCV genotype 1 containing the Q80K polymorphism demonstrated significantly lower response rates to treatment with OLYSIO. Approximately one-third of HCV patients have virus with Q80K polymorphism. Given the high frequency of the Q80K polymorphism and its significant impact on OLYSIO’s success rate, it is recommended that patients be screened for the Q80K polymorphism prior to treatment.
LabCorp and Monogram Biosciences, Inc., a member of the LabCorp Specialty Testing Group, were the first to launch an HCV drug resistance test for NS3/4A protease inhibitors. In addition to OLYSIO, LabCorp’s HCVGenoSure NS3/4A test also provides resistance information for the drugs VICTRELIS ® (boceprevir) and INCIVEK ® (telaprevir). With the inclusion of all three FDA approved protease inhibitors, HCV GenoSure NS3/4A enables healthcare providers to select the most appropriate therapy regimen for their patients.
An estimated 3.2 million people in the U.S. (and 170 million worldwide) are chronically infected with HCV, which if left undiagnosed and untreated can lead to liver fibrosis, cirrhosis and hepatocellular carcinoma. The Centers for Disease Control and Prevention (CDC) estimates that nearly half of the U.S. HCV population is currently undiagnosed, and the slow and often silent onset of HCV disease presentation has prompted more aggressive efforts to proactively diagnose and treat HCV infection. “We are proud to be a leader in the growing effort to screen and monitor individuals with HCV and to support physicians in treatment decisions to improve patient outcomes,” said David P. King, Chairman and CEO.