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GENFIT and LabCorp Sign a Licensing Agreement to Expand Access to an Innovative Diagnostic Assay for Non-Alcoholic Steatohepatitis (NASH)

LabCorp, a leading global life sciences company, and GENFIT, a biopharmaceutical company focused on discovering and developing drug candidates and diagnostic solutions targeting liver diseases, have announced the signing of a licensing agreement between GENFIT and Covance, LabCorp’s drug development business. The agreement will expand access to an innovative non-alcoholic steatohepatitis (NASH) liver diagnostic test for the clinical research market.

LabCorp Announces Launch of New Companion Diagnostic for Non-Small Cell Lung Cancer

Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH) recently announced the availability of a new application for the companion diagnostic associated with the use of Tarceva® for the treatment of certain patients with non-small cell lung cancer (NSCLC). The Roche cobas® EGFR Mutation Test v2 is the first blood-based test approved for clinical use in the U.S. to detect certain epidermal growth factor receptor (EGFR) gene mutations in NSCLC patients. LabCorp played a key role in making the test available upon approval by the U.S. Food and Drug Administration (FDA) and is the only national laboratory currently offering the test.

LabCorp Announces the Availability of the RealStar Zika Virus Test

Laboratory Corporation of America® Holdings (LabCorp®) (NYSE:LH) today announced the nationwide availability of testing for Zika virus using the RealStar® Zika Virus RT-PCR Kit U.S. from altona Diagnostics GmbH. The test has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the qualitative detection of Zika virus RNA in serum or urine (collected alongside a patient-matched serum specimen). It is intended to be used to aid in the diagnosis of Zika virus infection in individuals meeting clinical and/or epidemiological criteria for infection risk established by the Centers for Disease Control and Prevention (CDC).

LabCorp Announces the Launch of the Epi proColon Test for Colorectal Cancer Screening

Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH) today announced the launch of Epi proColon®, a blood-based test for colorectal cancer screening that was approved on April 13, 2016 for clinical use by the U.S. Food and Drug Administration (FDA). Epi proColon® is the first FDA-approved DNA based blood test for colorectal cancer. The test was developed by Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY) and is available under a joint commercialization agreement with Polymedco, Inc. in North America. LabCorp, the world’s leading healthcare diagnostics company, is the first laboratory in the U.S. to offer this FDA-approved, blood-based colorectal cancer screening test.

LabCorp to Offer New PD-L1 Test for Bristol-Myers Squibb’s OPDIVO Following Collaboration in Clinical Trial

Laboratory Corporation of America [®] Holdings (LabCorp [®] ) (NYSE: LH) recently announced the nationwide availability of a new FDA-approved diagnostic test for PD-L1 associated with the expanded approval of Bristol-Myers Squibb Company’s (BMS) OPDIVO [®] (nivolumab) for the treatment of all appropriate patients with previously-treated non-small cell lung cancer (NSCLC). The PD-L1 IHC 28-8 pharmDx assay was developed by Dako, an Agilent Technologies company. The assay was used to assess PD-L1 expression in the Phase 3 CheckMate 057 trial, in which OPDIVO demonstrated superior overall survival compared to chemotherapy in patients with previously treated metastatic non-squamous NSCLC. This approval expands the indication for OPDIVO to include previously treated non-squamous NSCLC in addition to the squamous NSCLC indication. The test, although not required for OPDIVO, is a new tool that provides physicians with information on the potential survival benefit of treatment with OPDIVO.