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SOURCE Eutropics Inc.
Approval to Begin Clinical Laboratory Operations in Support of PraediCare-Dx™ Portfolio
CAMBRIDGE, Mass., June 16, 2014 /PRNewswire/ -- EUTROPICS Inc., a privately held company developing novel diagnostic tests that provide predictive insights to cancer patient response to treatment, today announced its laboratory, located in Cambridge, MA, has received Clinical Laboratory Improvement Amendment (CLIA) certification from the U.S. Department of Health and Human Services' Centers for Medicare and Medicaid Services (CMS) for its clinical diagnostics laboratory in Cambridge, Massachusetts. This certification follows receipt of a Massachusetts State license and allows the company to accept clinical samples from most U.S. states. The Milestone Clears the Path to Launch of PraediCare-Dx™.
"With CLIA certification, Eutropics has proven capability in executing complex testing in a highly regulated environment. Our platform technology is now ready for hematology oncology clinicians to guide selection of treatment options that will best help patients," said Michael Cardone, PhD, CEO of Eutropics. "This certification is essential in transitioning the diagnostic platform from a research assay to a clinical assay."
"Today we have limited tools to predict therapeutic patient outcomes in hematologic malignancy. The predictive diagnostic provided by PraediCare-Dx has promise informing treatment options in AML, where the test would have immediate impact on patient care," said Raoul Tibes, MD, PhD, Director of the Acute and Chronic Leukemia Program, Division of Hematology, Mayo Clinic and Mayo Clinic Cancer Center, Scottsdale, who also added, "Obtaining CLIA certification is a significant milestone in the process of bringing this technology to patients."
Eutropics is scheduled to complete clinical verification studies in AML and make the test available to physicians by December 2014.
Eutropics' technology platform, PraediCare-Dx, delivers medically useful in vitro diagnostic assays. The tests may improve patient outcome by directing the best treatment options and provide a biomarker for guided cancer drug development. Based on clinical evidence, PraediCare-Dx delivers unique understanding into a cancer cells' ability to respond to chemotherapies that induce programmed cell death (apoptosis), enabling the physician to choose the treatment option most likely to benefit the individual patient. Tests based on the PraediCare-Dx technology are being investigated for use in treating acute myeloid leukemia, chronic lymphocytic leukemia, and multiple myeloma. For more information, please visit the company's website at www.eutropics.com.
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