GenMark Receives Medical Device Manufacturing License for its Carlsbad Facility

March 17, 2011

CARLSBAD, Calif.--(BUSINESS WIRE)-- GenMark Diagnostics (Nasdaq:GNMK) today advised it has received notice from the California State Food and Drug Branch, that following a recent audit of its new Carlsbad facility, it has been issued with a medical device manufacturing license, enabling the company to manufacture and distribute all its existing and future products from this facility. All operations at its Pasadena facility, which had been the source of all manufacturing and distribution for the company, will cease at the end of March 2011.


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 five 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.

GenMark Diagnostics, Inc.
Christopher Gleeson
Chairman and Chief Executive Officer

Source: GenMark Diagnostics

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