Genomics USA (GenUSA) has developed a plan to penetrate the new and rapidly growing personalized medicine marketplace, based on the development of its unique micro array technology. The beach-head product in this market is "The HLA Chip" which is based on Human Leukocyte Antigen (HLA) typing: with proven market applications for tissue transplantation and stem cell therapeutics; and early stage but high-growth-potential markets, also based on HLA analysis, for vaccine development, personalized vaccine delivery, personalized treatment for autoimmune diseases (MS, Arthritis), and personalized treatment of microbial infection. Follow-on GenUSA products in the personalized medicine market will service chemical therapeutics: especially those applications where personal genetic variation at a number of gene sites can cooperate to alter treatment responsiveness: as in obesity, depression and cardiovascular risk. The underlying feature of all these gene-based medical applications is a focus on sets of 100-300 single nucleotide polymorphisms (SNPs) in parallel. Because of GenUSA's unique micro array technology, the company can develop highly accurate SNP-based test panels as high quality, low cost, simple-to-use micro array products, with specialized content based on an advanced, proprietary GenUSA bio-informatics platform. As the GenUSA entry into the clinical proteomics market, the Company plans to develop a "Transplantation Chip" based on GenUSA protein micro array technology.

The accuracy, simplicity and cost effectiveness of the "HLA Chip" is expected to expand the current proven market for HLA genotyping by at least a factor of three within five years and a factor of ten within 7 years, as HLA typing is enabled as a routine component of vaccine development, vaccine delivery, an expanded tissue typing market (including stem cell therapy) and as a method of patient stratification for autoimmune diseases (MS, Arthritis). We will focus the first two years of GenUSA commercialization activity on development of The HLA Chip, plus related manufacturing and informatics technologies.

GenUSA has established a collaboration with Mayo Clinic, which is one of the world's leading centers for clinical studies. They will validate the technology in a CLIA certified diagnostic setting. By the end of year three, GenUSA will have developed an HLA Chip that has been validated for vaccine response at a population scale. The product could be launched for beta testing for the research market within this time frame. For the medical R&D and vaccine development market, GenUSA plans to sell micro arrays and related consumables directly to the research community (the top 20 academic and industrial labs). The clinical HLA market will be serviced as a joint venture with an established supplier of CLIA-certified genetic tests, who has a leading market presence. Such a relationship could be established as a joint venture, or OEM sales agreement by 2008. The Company's plan is to first introduce a general HLA Chip consisting of about 200 -300 SNPs that have a demonstrated correlation to several indications such as organ transplantation, vaccine response. Rheumatoid Arthritis etc. The follow-on products could include several focused HLA Chips each one consisting of a subset of SNPS (may be 50 or so SNPs) that have direct correlation to one specific indication only.(e.g. a chip for organ transplantation, a chip for vaccine response etc.) Pilot Scale production will continue to be carried out in-house while large scale manufacturing is likely to be contracted out. However, we believe that before the low cost GenUSA micro array technology can become a standard in such population-scale genetics, it will be necessary to find ways to couple GenUSA products to technologies that will simplify and standardize DNA acquisition, shipping, processing and storage.

Based upon that belief, GenUSA has set out to couple its micro array platform to recent technological advances in DNA processing, especially the dry state "FTA" sample storage technology first championed by Whatman Biosciences, then subsequently enhanced and automated by GenVault Inc, to support the creation and management of room temperature DNA archives in the 10,000 to 1MM sample range. GenUSA has begun the development of an HLA micro array to be used for "ZIP-code-scale" deployment of genetic immunology to support vaccine delivery and infectious risk evaluation. The front end of the HLA Chip technology is driven by the acquisition and storage of mouthwash on modified FTA. Mouthwash and mouthscrapes have recently been validated as the method of choice for epidemiological and forensic DNA collection by the NIH and FBI, respectively. GenUSA is developing an inter phase which allows DNA extraction, labeling and micro array hybridization to be performed on thousands of individuals per week, from such dry-state human DNA samples, in a field-ready environment.