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LabCorp Contributes to Clinical Research Collaborations Directed at Advancing Treatment of Breast Cancer and Viral Hepatitis

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Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH) recently highlighted clinical research efforts in oncology and viral hepatitis that demonstrate its commitment to novel diagnostic capabilities and unique bioinformatics resources to enhance patient care in today’s rapidly evolving healthcare system.

A study published in the February 1 issue of Clinical Cancer Research (21(3): 569-576) illustrates how the HERmark® Breast Cancer Assay (HERmark) can identify certain breast cancers that over-express HER2 and that are most likely to provide patients with increased clinical benefit from dual agent HER2 therapy, compared to single agents alone. HERmark is a novel diagnostic test, available exclusively from LabCorp through Monogram Biosciences, Inc., a member of the LabCorp Specialty Testing Group. HERmark uses patented VeraTag® technology to provide quantitative measurements of HER2 protein expression in formalin-fixed, paraffin-embedded (FFPE) breast cancer samples.

This study has important potential implications for treatment of HER2-positive breast cancer, including sparing patients from adverse side effects of dual therapy, and conversely, focusing dual therapy on patients most likely to benefit from a second HER2-targeted agent. Approximately 20% of breast cancer patients have tumors that are characterized by the over-expression of the HER2 cell surface receptor, and multiple HER2 targeted therapeutic approaches are routinely used to treat primary and recurrent/metastatic HER2 positive breast cancer. Commenting on the study, Dr. Marcia Eisenberg, LabCorp Diagnostics’ Chief Scientific Officer, remarked “The HERmark Breast Cancer Assay is a great example of how LabCorp is utilizing its scientific and diagnostic expertise to address the healthcare system’s demand for enhanced patient outcomes at lower costs.”

In addition to clinical collaborations aimed at optimizing individual patient care through personalized medicine, LabCorp is collaborating with the U.S. Centers for Disease Control and Prevention (CDC) to advance public health initiatives combatting viral hepatitis. Chronic viral hepatitis is the leading cause of liver failure, liver transplantation and hepatocellular carcinoma, which is now the fastest growing cause of cancer-related deaths in the U.S. and is the second leading cause of cancer deaths worldwide. Because chronic viral hepatitis can remain asymptomatic for many years, infected individuals are often unaware of their status until they develop clinical indicators that signify the onset of liver damage and disease progression. CDC has established initiatives to raise awareness of this disease, increase testing in at-risk populations and better insure that infected patients have an opportunity to initiate and continue treatment.

LabCorp is a leader in offering new and innovative diagnostic tests for viral hepatitis. LabCorp offers a comprehensive portfolio of assays based on antigen/antibody and nucleic acid detection that can identify and classify infection, determine viral genotype/subtype, quantitate viral replication, and evaluate the effectiveness of antiviral treatment, including the presence of pre-existing and acquired drug resistant variants. LabCorp also offers assays for host cell markers that are prognostic for disease progression and predictive for treatment outcomes, as well as serum necro-inflammatory biomarkers that can be used to assess the impact of disease on liver function. LabCorp has partnered with CDC through a three year collaboration that will provide the agency access to LabCorp’s extensive data stores of viral hepatitis test results. The agreement will enable the CDC to use de-identified test results to evaluate trends and patterns in hepatitis virus test results to enhance patient care.

“The viral hepatitis collaboration with the CDC, and the HER2 study focused on advancing personalized medicine, are the latest examples of LabCorp’s commitment to driving scientific innovation and developing knowledge services to improve healthcare,” stated David P. King, Chairman and Chief Executive Officer. “Initiatives like these are strong evidence of LabCorp’s position as the world’s leading healthcare diagnostics company, with unique capabilities to deliver value and solutions to all healthcare stakeholders.”

Study: Scaltriti et al. High HER2 Expression Correlates with Response to the Combination of Lapatinib and Trastuzumab. Clin Cancer Res. 2015 Feb 1;21(3):569-76. doi: 10.1158/1078-0432.CCR-14-1824. Epub 2014 Dec 2.

Source: LabCorp