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GenMark goes ALL-digital
CARLSBAD, Calif.—GenMark Diagnostics Inc., and Advanced Liquid Logic Inc. (ALL) have agreed to collaborate to develop an all-digital, fully integrated in-vitro diagnostic (IVD) platform, bringing together ALL's proprietary electrowetting technology and GenMark's proprietary electrochemical detection. The final agreements follow previous "heads of agreement" entered into by the two companies in March.
"This partnership will allow us to leverage both companies' unique technologies and know-how to deliver a digital sample-to-answer, in-vitro diagnostic platform," says Hany Massarany, president and CEO of GenMark. "Our initial focus on multiplex molecular testing will be followed by efforts in other areas of diagnostics including protein detection and point-of-care testing, as we redefine industry standards for performance, reliability and ease of use with even the most complex of assays."
"We are excited to be working with the GenMark team and technology," states Richard West, president and CEO of ALL. "We bring a unique capability in comprehensive, electronically driven sample preparation and we expect that it will integrate well with GenMark's eSensor detection technology. This further validates that the fluid-handling flexibility of our platform can be integrated with multiple types of detection for a wide range of applications."
ALL's technology can miniaturize and automate virtually any liquid handling problem, West says.
"The common theme across these collaborations and many of our other market opportunities is sample preparation, which has certainly been challenging for DNA sequencing and molecular diagnostics. Our unique technology enables us to deliver a very complex protocol on a relatively simple and inexpensive platform. In addition, we can integrate our liquid-handling technology with almost any type of detection technology: GenMark's eSensor detection technology is a good example, as is Luminex's bead-based detection technology."
In addition to the Luminex collaboration, ALL will provide instrumentation, software and digital microfluidic cartridge technology to NuGEN Technologies Inc., a developer of sample-preparation solutions for next-generation sequencing and genomic profiling applications, for commercialization.
ALL's digital microfluidic technology is based on the use of electrowetting to precisely manipulate droplets on a surface. Electrowetting describes the ability of an applied voltage to modulate the "wettability" of a surface. Aqueous droplets naturally bead-up on a hydrophobic surface but a voltage applied between a droplet and an insulated electrode can cause the droplet to spread on the surface. Digital microfluidics harnesses the electrowetting effect to precisely manipulate droplets within a sealed microfluidic cartridge (also called a "lab on a chip"). Electrical signals are applied to an array of electrodes to control the size and position of each droplet. Droplets are transferred between adjacent electrodes by removing voltage from one electrode and applying it to the next one. The same processes can be used to dispense, merge or split droplets. Full programmable fluid handling is thereby achieved without the use of any pumps, valves or channels.
ALL has developed methods for implementing many bioassay protocols using digital microfluidics. Examples include: quantitative analysis of DNA (qPCR) and RNA (RT-qPCR); protein analysis using both enzymatic and immunoassay techniques; DNA sequencing using a sequencing-by-synthesis method; sample preparation from many different sample matrices (blood, swabs, saliva, etc.); and preparation of fragment libraries for next-generation sequencing. The privately held company states that it is "rapidly growing and profitable." ALL is headquartered in Durham, N.C., with additional facilities in Grenoble, France.
GenMark provides automated, multiplex molecular diagnostic testing systems that detect and measure DNA and RNA targets to diagnose disease and optimize patient treatment. Utilizing GenMark's proprietary eSensor detection technology, the eSensor XT-8 system is designed to support a broad range of molecular diagnostic tests with a compact, easy-to-use workstation and self-contained, disposable test cartridges. GenMark currently markets three tests that are cleared by the U.S. Food and Drug Administration (FDA) for IVD use: the Cystic Fibrosis Genotyping Test, the Warfarin Sensitivity Test and the 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, and KRAS, are in development for IVD use.