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Gene Express was established in 1992 and the Research and Development activities have been funded by National Institutes of Health and National Cancer Institute grants, friends and family to approximately $9.5 million. This includes, also, a $1 million 2-year grant won in 2003 from the State of Ohio Technology Action Fund to commercialize the business. In 1997 the company's technology received its first of three foundation patents. Other patents, domestic and international, are pending. The creation of StaRT-PCRTM gene reagents began in 1999. In 2001 the first employees were hired. In October, 2002 the Company began to hire professional management to build Gene Express and commercialize its products. Gene Express developed Standardized Operation Procedures (SOPs) for the Production Lab for the manufacturing of Standardized Mixtures of Internal StandardsTM (SMISTM) and gene-specific primers. In addition, Standardized Operation Procedures (SOPs) were developed for the Standardized Expression Measurement (SEM) CenterTM GLP Service. Both the Production Lab and SEM CenterTM
GLP Service operate under the FDA Good Laboratory Practice (GLP) regulations (21 CFR Part 58) and in compliance with Gene Express' defined and tested SOPs (Standardized Operation Procedures). Gene Express is growing with Blue Chip Customers; in 2004 the first project was successfully completed under a two-year global sales agreement with Pfizer, Inc. Now four Pfizer projects have been completed. Pfizer has adopted StaRT-PCRTM for clinical trials activities. Additional customers include Lilly, Amgen, Wyeth and Affymetrix.
With the support of Pfizer, the National Cancer Institute and FDA, Gene Express is developing a Standardized Genomics Oncology Consortium with the goal of build StaRT-PCRTM Assays for the Top 1000 genes associated with Cancer.
To address the primary commercial product objective of the Company, four molecular diagnostic products have been developed that focus on accurately diagnosing and treating lung cancer. Based on a National Cancer Institute grant of $1.2 million the product providing a more accurate diagnosis of lung cancer is in multi-center clinical trials at the New York University Hospital, the Memorial Sloan Kettering Cancer Center, the University of Pittsburgh and the Medical University of Ohio. In cooperative efforts with the University of Southern California, the stages or the disease progression in Bladder Cancer has been identified with StaRT-PCRTM gene expression Indices. In a recent study commissioned by Pfizer, Gene Express defined normal ranges of gene transcript values in whole blood. This enables the definition of diseases like diabetes, inflammation, cardiovascular and others to be determined from gene expression measurement in blood. Using StaRT-PCRTM, we are developing measurement for blood cultures in hours, not days and will identify infection from all 100 or so bacteria and viruses that attack humans. |