LabCorp to Offer a New Companion Diagnostic for Melanoma

Laboratory Corporation of America® Holdings (NYSE: LH) announced today the nationwide availability of a new FDA-approved diagnostic for melanoma patients. The drug ZelborafTM and the cobas® 4800 BRAF V600 Mutation Test companion diagnostic, both from Roche, were approved by the FDA on August 17 for use in patients with inoperable or metastatic melanoma with the BRAFV600E gene mutation. The companion diagnostic is now available through LabCorp under the name BRAF Gene Mutation Assay, Melanoma. This test detects the BRAFV600E gene mutation within the tumor sample and is the only diagnostic that has been clinically validated and FDA approved to identify patients eligible for treatment with Zelboraf. An estimated 9,000 individuals will develop advanced melanoma in the United States in 2011, and of these 50% will have the BRAFV600E mutation.