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Genome Data Systems Using $2M From NIH to Develop Microfluidic Cell-Based Assay Tool

Startup biotech Genome Data Systems, in the fourth year of a five-year grant from the National Institutes of Health, is using what’s left of the $2 million award to prepare for market a mirofluidic-based, miniaturized cell-based assay platform, CBA News learned this week.
Although the company hasn’t said when it plans to begin selling the product, it said it would partner with pharmaceutical companies in the “near future” for beta-testing, and will eventually use the platform for contract research services and to conduct internal lead-discovery research.
GDS describes the technology, dubbed GeneCard, as a “modular approach to microfluidics that allows both easy introduction and removal of cells, tissues, and other solid-phase materials into fluidic devices.”
Specifically, the technology comprises a fluidic chip with a fluid inlet and outlet, as well as another port, to introduce a GeneCard substrate into the chip. Upon introduction of this substrate, a fluidic device is formed with a chamber enclosed between the adjacent surfaces of the GeneCard and the chip, according to a summary of the technology provided by GDS.
“‘Through-holes’ in the chip provide easy access to the chamber,” according to the summary. “The GeneCard substrate can be used to culture cells in relatively large volumes, or can contain attached cells, tissues, or molecules on its surface that can be exposed to a fluid flowing through the assembled device.”
According to Rajan Kumar, founder and CEO of GDS, the principal idea of GeneCard is to perform small-volume cell-based assays in 96-well plates.
“The technology is applicable to any adherent cell type, which includes most carcinoma cell lines,” Kumar told CBA News this week. “There is an injection-molded consumable component that is used to prevent evaporation from wells. Hardware under development will be an automated handling system for both the consumable component and for reagents such as cell culture medium and drug compounds.”
Kumar founded the company in 2001 to commercialize microfluidics technologies he invented. Kumar said that at his previous position with engineering firm Sarnoff, he contributed to the technical development of Orchid Biosciences, and several of his patents were eventually licensed to Orchid for use in its microfluidics-based SNP detection platform.
Kumar also said he was the program manager of a Defense Advanced Research Projects Agency-funded contract to develop a hand-held microfluidics-based biological detector for detecting pathogens by microscale DNA amplification and protein analysis. Kumar founded GDS with the intention of applying his microfluidics experience to cell-based assays.
GDS’s efforts have thus far been well-funded. The NIH’s National Institute of Diabetes and Digestive and Kidney Diseases awarded GDS a $250,000 Phase I SBIR grant in 2002.
Following the successful completion of that project, NIDDK doled out another $608,000 in Phase II SBIR cash to GDS in 2004; $644,000 in 2005; and $693,000 this year. According to GDS’ grant abstract, the project is set to end in April 2007. It is unclear whether GDS stands to receive additional funding after this year.
Furthermore, the company’s first grant, for an undisclosed amount, was from DARPA and “launched [GDS] in the cell-based assay track,” while the company has also received a $115,000 loan-grant from the New Jersey Commission on Science and Technology. Lastly, GDS has received Phase I SBIR funding from the Department of Energy and NIH for exploring protein-protein interaction analysis and endothelial cell assays using the technology.
Thus far, GDS has successfully designed, fabricated, and tested GeneCard devices for growing and assaying multiple cancer cell lines, including the breast cancer cell line MCF-7, and the colon cancer cell lines DLD-1 and VM-10. In addition, GDS has successfully cultured and tested human fibroblast NIH-3T3 cells and fish chromatophores.
According to the company, GeneCard’s closest competitors include technologies developed by CyBio and The Automation Partnership, while other fringe competitors include Caliper, Aclara, Tecan, Protedyne, and Beckman Coulter.
“Microfluidics cell-based assays have been described previously,” according to the company’s summary. “[But] all microscale approaches suffer from the difficulty of introducing adherent cells into microfluidic devices. GeneCard architecture resolves this important problem by separating [the] cell growth and cell assay steps.”
GDS said the advantages of GeneCard over existing technologies include low screening costs due to assay miniaturization; compatibility with current instrumentation infrastructure at pharmaceutical companies; enhanced assay speed; and greater accuracy and reproducibility.
One technology that GDS does not name as a potential competitor is the CellCard, formerly marketed by now-defunct Vitra Biosciences, and currently owned by Millipore’s Serologicals division. Although CellCard is not based on microfluidics – it uses 500-by-300-micron color-coded cards on which different cell types can be cultured and assayed – it does claim to confer many of the same advantages as GeneCard. The current status of that technology is unknown.
GDS believes that the top-50 pharma companies and top-100 medium to large biotechnology companies will be interested in buying GeneCard systems, noting that the pharmaceutical industry spends approximately $8 billion to $9 billion on discovery research, “which includes high-throughput screening, the target market for the proposed system.”
Kumar declined to provide a specific timeline for commercialization of GeneCard, but the company is currently using its SBIR stash to build prototype platforms, which it will then attempt to place for beta-testing at pharmaceutical companies. GDS also plans to out-license the manufacture of the GeneCard systems to a GMP-compliant manufacturer, while providing chips, associated reagents, and controls, the company said.

Finally, Kumar told CBA News that the company plans to provide contract cell-based screening services to pharmaceutical partners, and that GDS will identify and out-license lead compounds identified using its technology to generate revenue for future in-house R&D activities.

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