Eutropics Pharmaceuticals Approved to Perform Patient Samples Testing
Eutropics can now begin clinical laboratory operations for the PraediCare Dx™ portfolio of diagnostics tests
Cambridge, MA, September 20, 2013 - Eutropics Pharmaceuticals Inc. announced today that Eutropics successfully concluded its Massachusetts state inspection yesterday and has been approved to perform patient samples testing under the Massachusetts Department of Public Health Clinical Laboratory Program.
This approval to operate as a Massachusetts licensed CLIA registered lab marks a significant milestone for Eutropics, allowing the company to begin clinical laboratory operations for the PraediCare Dx™ portfolio of diagnostics tests at our Cambridge, MA labs.
Eutropics is positioned to provide this important technology for guiding drug development and use.
About PraediCare Dx
Eutropics’ PraediCare Dx platform technology delivers medically useful in vitro diagnostic assays. The tests may improve patient outcome by directing the best treatment options and also may provide a biomarker for guided cancer drug development. Based on clinical evidence, the PraediCare Dx technology platform delivers unique understanding into a cancer cell’s 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 myelogenous leukemia (AML) and multiple myeloma (MM). A recently completed validation study in uniformly treated AML patients indicate that the test provides actionable data to physicians. PraediCare Dx is currently being verified in repeat studies with academic and pharmaceutical partners. These validation studies for predicting response to standard-of-care are anticipated to be completed in fourth quarter of 2013. Tests for CLL, ALL and DLBCL have been developed for future clinical studies.
About Eutropics Pharmaceuticals
Eutropics is addressing the need for improving the treatment of aggressive forms of leukemia, myeloma, lymphoma, and other cancers. The company is developing a novel diagnostic technology that will guide the use of established and experimental therapeutics, enabling the delivery of personalized medicines to patients suffering from cancer. <a href="http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.eutropics.com&esheet=50633741&lan=en-US&anchor=www.eutropics.com&index=1&md5=42373b284dbd2b682f5b1f49a00e6a4a" data-rapid_p="1">www.eutropics.com
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