GenMark Dx is an industry leader in multiplex molecular diagnostics

Sept. 1, 2012

GenMark’s vision is to be a leader in multiplex molecular diagnostics. We provide high medical value, easy to perform tests that improve patients’ lives. Our expertise is in the design, development, and commercialization of molecular systems and assays based on our proprietary electrochemical detection technology called eSensor®.

The eSensor XT-8 System represents an advance in technology during an era of increasing growth in molecular diagnostics. Our proprietary electrochemical detection technology and innovative XT-8 System provide our customers with accurate, standardized assays that improve the efficiency of the laboratory. GenMark’s eSensor technology does not suffer from interferences that impact other detection technologies. Fluorescence, chemi-luminescence, and other “optical-based” detection systems have very limited multiplexing capabilities. By comparison, eSensor can accurately detect up to 72 targets on the same test cartridge.

Furthermore, our technology does not require lasers, cameras, or washing, so our system is very simple, with no moving parts or any waste generated. The value to our customers is testing that involves minimal hands-on time. The system provides automated result interpretation and requires no calibration or routine maintenance.

Hany Massarany

President and Chief Executive Officer


President and Chief Executive Officer and member of the Board of Directors at GenMark Diagnostics since April 2011; prior to that, served as President of Ventana Medical Systems and Head of Roche Tissue Diagnostics; held various global leadership positions with Ventana, Bayer Diagnostics, and Chiron Diagnostics.


BS in Microbiology and Immunology from Monash University, Australia; MBA from Melbourne University, Australia.


Married with two children; enjoys family activities including traveling; participates in several sports including running and cycling.

GenMark multiplex molecular diagnostic tests are FDA-cleared. GenMark currently markets three tests that are FDA cleared for IVD use: Cystic Fibrosis Genotyping Test, Warfarin Sensitivity Test, and Thrombophilia Risk Test. A Respiratory Viral Panel (RVP) has been submitted to the FDA for 510(k) clearance. A number of other tests, including HCV Genotyping and 2C19, versions of which are available for research use only, are in development for IVD use.

How IVD tests fit into the company menu. One core capability at GenMark is our comprehensive and rigorous quality and regulatory processes that are designed specifically to support IVD tests. Molecular diagnostics, and specifically multiplex molecular tests, remain far behind other areas of diagnostics with respect to the availability of IVD tests. We view IVD tests as a critical unmet need for our customers. We will continue to collaborate with the FDA to advance new IVD tests through the regulatory processes as part of our strategy.

Products and solutions have evolved to meet changing customer needs. Our eSensor technology and XT-8 System have allowed many laboratories to adopt multiplex testing that they were not previously able to do because complex test procedures or workflows did not support the test volumes or turnaround time requirements. With our RVP test customers have demonstrated that they can complete their daily test volumes comfortably with a single system and in a single shift, something that is not possible to achieve with most other methods.

In the future, we will bring a sample-to-answer system to the market that will fully automate the entire test process from extracting the sample to reporting results. This system is advancing through development as planned, and we expect to launch it in the second half of 2013.

GenMark’s company culture. Our company’s culture revolves around a set of core beliefs focused on empowering customers and enabling scientific innovation and collaboration. As CEO, I empower the organization to have complete ownership of our clearly defined goals, with a critical eye to maintaining an enriching and gratifying work environment.

GenMark supports the community through charitable enterprises. GenMark is active in our local community in many ways. Recently, we organized a series of fundraising activities to support our local Cystic Fibrosis Foundation chapter culminating with our company’s participation in the Great Strides event held in Del Mar, California, on May 6, 2012.

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