Creating Molecular Diagnostic Indices Gene Express, Inc. has created a clinical molecular diagnostics and pharmacogenomics process that can generate medical diagnostic rules for many types of diseases. In addition to the company's technology, Gene Express is working with two strategic partners. First, on the front end of our
StaRT-PCR technology, one partner has access to normal and diseased tissues samples and has the most experience with RNA extraction in different types of tissues. Second, on the back end of our technology, after Gene Express produces the number of standardized molecules of gene expression, we are beginning to co-market analytical software. This machine learning software is producing molecular diagnostic, predictive and pharmacogenomics rules for innovative molecular diagnostic tests and individually designed pharmacogenomics drugs. These innovated treatment diagnostics are expected to change the practice of medicine including reducing both the cost and time for the development of new drugs.
Commercialization of Molecular Diagnostic Products Currently, Gene Express is seeking strategic partners to help commercialize these molecular diagnostic tests. We will offer initially our lung cancer molecular diagnostic tests as home brew tests only as a service in a CLIA (Clinical Laboratory Improvement Amendments) SEM Center. This strategy will allow earlier market entry and allow early capital resources to be used for purposes other than the regulatory approval process. Molecular Diagnostics tests that are successful in the SEM service Center, and/or are promising from the beginning, will be converted to kits and submitted for FDA approval.
New StaRT-PCR Assays The sequencing of the genome facilitated the Company's efforts to develop and commercialize its
StaRT-PCR assay reagents since the sequence is a prerequisite to the preparation of the
StaRT-PCR gene's Internal Standard. The component reagents to conduct
StaRT-PCR assays are gene specific forward and reverse primers and competitive template internal standards that are formulated into Standardized Mixtures of Internal Standards (SMIS). These
StaRT-PCR reagents are manufactured under controlled Good Laboratory Practice (GLP) with stringent quality control (QC) and quality assurance (QA) performed and in addition to the quality assurance (QA) tests conducted on new SMIS in the Standardized Expression Measurement (SEM) Center. Gene Express is currently developing additional gene expression
StaRT-PCR tests. It is estimated that 5000 to 10,000 genes could have commercial application and thus patented
StaRT-PCR assay reagents would be produced for these genes.
Analysis of Protein and Gene Transcript Abundance Measurements in the Same Sample Gene Express is currently developing methods that will be able to conduct protein and gene expression tests on the same sample in the near future. Both of these measurements may be important in developing clinical biomarkers and molecular diagnostic products. A patent has been submitted for a method that enables these analyses. The method enables measurement of proteins, drugs and other clinically important molecules with all of the performance characteristics of
StaRT-PCR. Specifically, the linear dynamic range will be greater than 8 orders of magnitude and the lower detection threshold will be less than 10 molecules. This lower detection threshold is three orders of magnitude better than that for mass spec or microarrays, and 5 orders of magnitude better than for classic immunoassays.