GenMark goes ALL-digital

CARLSBAD, Calif.—GenMark Diagnostics Inc., and AdvancedLiquid 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 technologyand GenMark's proprietary electrochemical detection. The final agreementsfollow previous "heads of agreement" entered into by the two companies inMarch.

"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, presidentand CEO of GenMark. "Our initial focus on multiplex molecular testing will befollowed by efforts in other areas of diagnostics including protein detectionand 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 andtechnology," states Richard West, president and CEO of ALL. "We bring a uniquecapability in comprehensive, electronically driven sample preparation and weexpect that it will integrate well with GenMark's eSensor detection technology.This further validates that the fluid-handling flexibility of our platform canbe integrated with multiple types of detection for a wide range ofapplications."

ALL's technology can miniaturize and automate virtually anyliquid handling problem, West says.

"The common theme across these collaborations and many ofour other market opportunities is sample preparation, which has certainly beenchallenging for DNA sequencing and molecular diagnostics. Our unique technologyenables us to deliver a very complex protocol on a relatively simple andinexpensive platform. In addition, we can integrate our liquid-handling technologywith almost any type of detection technology: GenMark's eSensor detectiontechnology is a good example, as is Luminex's bead-based detection technology."

In addition to the Luminex collaboration, ALL will provideinstrumentation, software and digital microfluidic cartridge technology toNuGEN Technologies Inc., a developer of sample-preparation solutions fornext-generation sequencing and genomic profiling applications, forcommercialization.

ALL's digital microfluidic technology is based on the use ofelectrowetting to precisely manipulate droplets on a surface. Electrowettingdescribes the ability of an applied voltage to modulate the "wettability" of asurface. Aqueous droplets naturally bead-up on a hydrophobic surface but avoltage applied between a droplet and an insulated electrode can cause thedroplet to spread on the surface. Digital microfluidics harnesses theelectrowetting effect to precisely manipulate droplets within a sealedmicrofluidic cartridge (also called a "lab on a chip"). Electrical signals areapplied to an array of electrodes to control the size and position of eachdroplet. Droplets are transferred between adjacent electrodes by removingvoltage from one electrode and applying it to the next one. The same processescan be used to dispense, merge or split droplets. Full programmable fluidhandling is thereby achieved without the use of any pumps, valves or channels.

ALL has developed methods for implementing many bioassayprotocols using digital microfluidics. Examples include: quantitative analysisof DNA (qPCR) and RNA (RT-qPCR); protein analysis using both enzymatic andimmunoassay 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. Theprivately held company states that it is "rapidly growing and profitable." ALLis headquartered in Durham, N.C., with additional facilities in Grenoble,France.

GenMark provides automated, multiplex molecular diagnostictesting systems that detect and measure DNA and RNA targets to diagnose diseaseand optimize patient treatment. Utilizing GenMark's proprietary eSensordetection technology, the eSensor XT-8 system is designed to support a broadrange of molecular diagnostic tests with a compact, easy-to-use workstation andself-contained, disposable test cartridges. GenMark currently markets threetests 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 theThrombophilia Risk Test. A Respiratory Viral Panel (RVP) has been submitted tothe FDA for 510(k) clearance. A number of other tests, including HCV Genotypingand 2C19, versions of which are available for research use only, and KRAS, arein development for IVD use.