GenMark Diagnostics Selected as Diagnostic Platform in Warfarin Clinical Trial
CARLSBAD, Calif., Sep 27, 2010 (BUSINESS WIRE) -- GenMark Diagnostics, Inc. (NASDAQ:GNMK), a provider of automated, multiplex molecular diagnostic testing systems, announced today that their eSensor(R) Warfarin Sensitivity Test has been selected for use in a new pivotal Warfarin clinical study; the WARFARIN Trial (Warfarin Adverse event Reduction For Adults Receiving genetic testing at therapy INitiation). The trial will seek to evaluate the value of genetic testing on reducing adverse events associated with Warfarin therapy.
Eligible patients in this clinical study will be reimbursed by the Centers for Medicare and Medicaid Services (CMS) through a temporary code developed to enable the implementation of pharmacogenomic testing under the Coverage with Evidence Development (CED) provision in the Social Security Act. GenMark's selection for use in the WARFARIN trial was made by Iverson Genetics. "We selected GenMark Diagnostics' technology for its ability to provide accurate and reliable results. The XT-8 allows fast processing and simple interpretation of patient results," stated Dean Sproles, CEO of Iverson Genetics.
"We are pleased to have our leading Warfarin Sensitivity Test selected for inclusion in this clinical study," said Christopher Gleeson, CEO of GenMark Diagnostics. "We believe that the ease of use of our eSensor XT-8 system provides a clear choice for diagnostic laboratories and research centers."
GenMark, a provider of automated, multiplex molecular diagnostic testing systems, detects and measures DNA and RNA targets to diagnose disease and to optimize the treatment of patients and is focused on developing and commercializing its eSensor detection technology. GenMark's XT-8 System is designed to support a broad range of molecular diagnostic tests with a compact and easy-to-use workstation and self-contained, disposable test cartridges. GenMark has developed four diagnostic tests for use with the XT-8 System, including its Cystic Fibrosis Genotyping Test, Warfarin Sensitivity Test and Thrombophilia Risk Test which have received clearance from the Food and Drug Administration. www.GenMarkDx.com.
About Iverson Genetics
Iverson Genetic Diagnostics is a leader in making actionable genetic information readily available to physicians in everyday practice. The mission of Iverson Genetic Diagnostics is to provide physicians with clinically relevant gene-based information to optimize therapy and enhance personal wellness for their patients. Through its gene-based health and treatment profiles, the company provides physicians with actionable genetic information to optimize clinical decision-making and patient care. Iverson Genetic Diagnostics is headquartered in the Seattle suburb of Bothell, Washington where it maintains CLIA and CAP certified genetic testing laboratories. In addition, the company operates two specialty-specific genetic testing labs through university relationships in Georgia and South Carolina. For more information, visit www.IversonGenetics.com. The Iverson laboratory in Atlanta is located at Morehouse School of Medicine.
SOURCE: GenMark Diagnostics, Inc.
GenMark Diagnostics, Inc.
Steven Kemper, 760-448-4303
Chief Financial Officer
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