Berlin (Germany) and Germantown, MD (U.S.A.), May 9, 2016 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, announced that Laboratory Corporation of America® Holdings (LabCorp®) is the first laboratory network in the U.S. to offer Epi proColon®, a blood-based test for colorectal cancer screening. Epi proColon® was recently approved by the U.S. Food and Drug Administration (FDA) and has been made available to laboratories in the United States under a joint commercialization agreement with Polymedco, Inc.
LabCorp, an S&P 500 company, is the world’s leading healthcare diagnostics company, providing comprehensive clinical laboratory services through LabCorp Diagnostics and end-to-end drug development support through Covance Drug Development. LabCorp is a pioneer in commercializing new diagnostic technologies and is improving people’s health by delivering the combination of world-class diagnostics, drug development services and technology-enabled solutions.
“We are excited that LabCorp is the first laboratory to launch Epi proColon® in the United States, where we were recently FDA-approved,” said Dr. Thomas Taapken, CEO/CFO of Epigenomics. “LabCorp´s strong commitment and broad commercial capabilities will significantly contribute to the successful market penetration of our blood-based colorectal cancer screening test. We are already extremely pleased with the initial interest from the laboratory community. Together with our partner Polymedco, we are focusing our efforts on market adoption of the Epi proColon®test.”
“Colorectal cancer is one of the most curable diseases when detected in its early stages and treated surgically,” said Dr. Mark Brecher, Chief Medical Officer for LabCorp Diagnostics. “Many people are not properly screened because they are reluctant to collect a stool sample or undergo a colonoscopy. Tested from a simple blood draw, Epi proColon® is a convenient, accurate alternative for those patients who should be screened for colorectal cancer. LabCorp is committed to delivering world-class diagnostics, and Epi proColon® will contribute to our mission to improve health and improve lives.”
About Epi proColon®
Epi proColon® is indicated for colorectal cancer screening in average-risk patients who choose not to undergo colorectal cancer screening by guideline-recommended methods, such as colonoscopy and stool-based fecal immunochemical tests (FIT).
Epi proColon® has received FDA approval, based on demonstration of safety and efficacy as established in three major clinical studies. The test also demonstrated its potential to increase significantly participation rates in colorectal cancer screening.
Epi proColon® is an in-vitro PCR (polymerase chain reaction) assay for the qualitative detection of Septin9 gene methylation in DNA isolated from the patient’s plasma. Cytosine residues of the Septin9 gene are methylated in colorectal cancer tissue, but not in normal colon mucosa. This tumor-specific methylation pattern can be used to detect cell-free DNA shed into the blood stream by tumor cells. Detection of colorectal cancer-derived DNA in blood plasma using the Septin9 methylation biomarker has been demonstrated, in multiple clinical studies, to be a reliable indicator of the presence of colorectal cancer. Epi proColon® has received approval from the U.S. Food and Drug Administration (FDA) and is currently marketed in Europe, China and selected other countries.
About colorectal cancer
The American Cancer Society projects there will be over 134,000 new diagnosed cases of colorectal cancer, and almost 50,000 deaths, from colorectal cancer in 2016 in the United States. Colorectal cancer remains the second-leading cause of cancer death in the United States. Although screening and early detection of colorectal cancer can save lives, about 35 percent of eligible U.S. patients are not being regularly screened. While the 5-year survival rate for early colorectal cancer (stage I) is 90%, only four out of ten cases are diagnosed at this early stage. According to the American Cancer Society, this is in part due to the underuse of screening
Epigenomics is a molecular diagnostics company focused on blood-based detection of cancers using its proprietary DNA methylation biomarker technology. The company develops and commercializes diagnostic products across multiple cancer indications with high medical need. Epigenomics’ lead product, Epi proColon®, is a blood-based screening test for the detection of colorectal cancer. Epi proColon® has recently received approval from the U.S. Food and Drug Administration (FDA) and is currently marketed in Europe, China and selected other countries. The company is based in Germany and the United States. For more information, visit www.epigenomics.com.
Laboratory Corporation of America® Holdings, an S&P 500 company, is the world’s leading healthcare diagnostics company, providing comprehensive clinical laboratory services through LabCorp Diagnostics, and end-to-end drug development support through Covance Drug Development. LabCorp is a pioneer in commercializing new diagnostic technologies and is improving people’s health by delivering the combination of world-class diagnostics, drug development services and technology-enabled solutions. With net revenue in excess of $8.5 billion in 2015 and more than 50,000 employees in approximately 60 countries, LabCorp offers innovative solutions to healthcare stakeholders. LabCorp clients include physicians, patients and consumers, biopharmaceutical companies, government agencies, managed care organizations, hospitals, and clinical labs. To learn more about Covance Drug Development, visit www.covance.com. To learn more about LabCorp and LabCorp Diagnostics, visit www.labcorp.com.
Since 1980, Polymedco has evolved into a leading manufacturer, marketer, and distributor in the clinical laboratory marketplace. Polymedco supplies clinical diagnostic test kits that are specialized in hematology and cancer screening. The Company is a world leader in non-invasive colorectal cancer screening technology.
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