Genomics USA (GenUSA) has developed a simple but unique and inexpensive micro array technology that is ideally suited population-scale genotyping applications. The GenUSA technology platform is based on the simple, non-covalent attachment of probe DNA to a surface. Our approach is unique, in an IP sense, and very different from other micro array technologies engaged in SNP detection. By exploiting the special properties of DNA that has self-assembled directly onto the micro array surface, GenUSA can fabricate micro arrays from inexpensive starting materials, thereby greatly reducing the cost of micro array manufacture. More importantly, the biophysical properties of these "self-assembling" DNA micro arrays allow GenUSA to perform SNP-based hybridizations simply and directly, without the need to perform single base extension or any other secondary biochemical treatment. That extreme simplification-of -use greatly reduces the cost of the product, increases signal quality and allows the product to be used by non-experts, especially in a field-testing or small-clinic environment.

The Company is developing an integrated micro array technology platform for such large-scale genotyping applications, which includes high throughput manufacture of DNA micro arrays and a suite of simplified bioinformatics tools for gene selection, micro array probe design, hands-free image analysis and data mining by the customer. GenUSA has a unique patent position relative to other companies in the complex micro array IP landscape. We believe that GenUSA is the only micro array company (including the major players) with a clear path to commercialization without the need for licensing additional IP from its competitors. The core GenUSA micro array technologies are protected by numerous patent claims, pending.

The core of the GenUSA technology platform is a very low cost and high throughput method to fabricate micro arrays and other similar solid state devices for the analysis of many gene sites in parallel. This technology was invented by the founders of GenUSA, while still at Baylor College of Medicine and has been exclusively licensed to GenUSA. For all other microarray technologies as currently practiced in the marketplace by Affymetrix, Agilent, Qiagen and others, micro arrays are fabricated by covalent attachment of DNA fragments to specific sites on the micro array surface to form an array of sites ("the micro array") 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 micro array surface and the resulting novel duplex form that results upon binding to it is the basis for the strong GenUSA IP position. However, the invention has direct practical ramifications that will allow GenUSA to dominate the clinical and population-scale micro array 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 GenUSA "self assembly" technology.

The existing micro array technologies all require that DNA fragments used to make a micro array are chemically linked to the micro array 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. Thus, the GenUSA technology, which does not require any modification, automatically associated with a 3 fold reduction in cost of goods.

Independent of nucleic acid cost, the GenUSA technology enables even larger cost savings, due to the intrinsic efficiency of the GenUSA manufacturing process. The chemical linkage process that is the basis for all alternative micro array technologies is intrinsically inefficient: whether the DNA is assembled on the micro array surface (as for Affymetrix or Agilent) 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 micro array surface. In the GenUSA 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 GenUSA can fabricate extremely high quality quality micro arrays to service a growing medical genomics, forensic and Homeland Defense market, at a cost of manufacture that is 1/10 of the other micro array technologies