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Technology

The core of the gmsbiotech technology platform is a very low cost and high throughput method to fabricate microarrays and other similar solid state devices for the analysis of many gene sites in parallel. This technology was invented by the founders of gmsbiotech, while still at Baylor College of Medicine and has been exclusively licensed to gmsbiotech. For all other microarray technologies as currently practiced in the marketplace by Affymetrix, Illumina and others, microarrays are fabricated by covalent attachment of DNA fragments to specific sites on a surface to form an array of sites ("the microarray") that can independently engage in DNA hybridization analysis with a complex solution state DNA mixture of interest: each DNA site on the micro array performing a unique DNA hybridization test. The spontaneous assembly of an orderly DNA monolayer on the microarray surface and the resulting novel duplex form that results upon binding to it, is the basis for the gmsbiotech IP position. However, the invention has direct practical ramifications that will allow gmsbiotech success in the clinical and population-scale microarray market. To understand the technical basis for that market distinction, it is necessary to recognize the cost savings and manufacturing simplicity that arise from the gmsbiotech "self assembly" technology.

The existing microarray technologies require that the DNA fragments used to make a microarray are chemically linked to the microarray surface. This requires that they be prepared as an expensive, chemically-altered DNA derivative, at a cost that is about 3 times greater than that if the same fragment were unmodified and that they are printed onto surfaces with (expensive) reactive chemical films. Thus, the gmsbiotech technology, which does not require any modification of the DNA and minimal (inexpensive) modification of the surface, automatically yields a 3-5-fold fold reduction in cost

Independent of nucleic acid cost, the gmsbiotech technology enables even larger cost savings, due to the intrinsic efficiency of the gmsbiotech manufacturing process. The chemical linkage process that is the basis for all alternative microarray technologies is intrinsically inefficient: whether the DNA is assembled on the microarray surface (as for Affymetrix) or linked to the surface after fabrication (as for most other companies). Thus, the current technologies typically require dispensing of a 10-fold excess of DNA, over that required to actually cover the microarray surface. In the gmsbiotech technology, the adsorptive self assembly is nearly quantitative, requiring no more that a one-fold excess of applied material. When the very low intrinsic cost of goods is paired with the increase in manufacturing efficiency, the net result is that gmsbiotech can fabricate extremely high quality microarrays to service a growing public health screening, medical genomics, forensic and Homeland Defense market, at a cost of manufacture that is a fraction of the other microarray technologies.

Finally, gmsbiotech has found a way to completely bypass DNA purification in its HLA-typing products: enabling routine HLA typing from a microliter (about 1/50th of a drop) of raw blood; or enabling HLA typing from about 1/10th of the dried blood in a single 2mm punch-out from a neonatal filter paper card; or enabling HLA typing from 1/50th of the rehydrated sample derived from an ordinary cheek swab. The ability to use such very simple collection approaches, and the ability to bypass DNA purification from them has great practical significance: In terms of logistics, it makes sample collection for HLA typing as simple and inexpensive as can be possible, in a way that fits naturally into existing, large-scale public health sample collection schemes. In terms of work-flow, it cuts in half, the time and the number of steps required to perform such HLA typing. And finally in terms of cost, it completely eliminates the cost of DNA purification from HLA-typing, thus reducing the cost per HLA test by about 50%.

In the aggregate, this suite of HLA-typing technologies is designed to allow, for the first time, routine high-resolution HLA-typing at the population-scale, on raw samples, at an aggregate cost that is drastically lower than that currently employed in solid organ transplantation.








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