Gene Express, Inc. utilizes a proprietary technology known as StaRT-PCR to standardize multi-gene expression, which is also called Transcript Abundance (TA) Measurement. Clients are using the patented StaRT-PCR Method to clinically validate biomarker assays. The technology is a preferred choice of researchers in the development of new drugs, theranostics and prognostics, clinical biomarkers and molecular diagnostic products. These researchers are utilizing StaRT-PCR for analysis of tissue, blood, xenografts, formalin fixation paraffin embedded (FFPE) samples and cell culture samples. Gene Express sells products and services to researchers and drug developers worldwide:

• SEM Center GLP Services (Standardized Expression Measurement Center Good Laboratory Practice Services)

• New Gene Assays Development for Internal Standard Products used in StaRT-PCR Gene Transcript Abundance Assays

• Pharmacogenomics Consulting Services

• Technology Licenses

StaRT-PCR technology supports the FDA's Guidance for Pharmacogenomic use in new drug development. StaRT-PCR is ground breaking technology and a true market disruptor. Our clients recognize that the data produced by StaRT-PCR has greater value than competing technologies. The affect of StaRT-PCR analytical test performance provides dramatic increase in the value of data produced by Gene Express' products and services. StaRT-PCR has the integrated quality control, standardization and reproducibility that is lacking in today's gene expression technology. The new regulatory guidelines that have been adopted and the desire of our clients to overcome these shortcomings have made StaRT-PCR the preferred technology of many researchers worldwide. Theses deficiencies prevent competing methods from moving beyond use in basic research and thus are not sufficient to support the FDA (Food and Drug Administration) regulatory process for new drug development nor are these methods useful for the development of theranostic and prognostic clinical biomarkers and molecular diagnostic products. The StaRT-PCR superior patented position is due to the presence of (1) patented competitive gene templates as Internal Standards for every target gene and every reference gene in every PCR reaction and (2) patented Standardized Mixtures of Internal Standards (SMIS). These features make StaRT-PCR as the only method that provides all the benefits of quantification, standardization and multi-gene Transcript Abundance Measurement.

StaRT-PCR has the highest sensitivity allowed by the PCR process, greater precision and more reproducibility quantification than existing technologies in the marketplace. These existing technologies also lack the standardization necessary in gene expression measurement. For the first time gene Transcript Abundance Measurements can be tested across the entire 7-log range of gene expression and results can be compared with other labs. Normal human clinical Transcript Abundance levels can be determined and molecular diagnostics can be developed. See Pfizer's 2005 DIA Presentation. Thus StaRT-PCR gives high reproducibility while maintaining high sensitivity. StaRT-PCR is highly specific and measures only the gene(s) of interest and is highly sensitive by being able to identify less than 10 molecules of mRNA.

SEM Center GLP Services
All of our StaRT-PCR assays are performed under strictly controlled GLP (Good Laboratory Practice) conditions employing our proprietary Standardized Mixtures of Internal Standards (SMIS) and gene-specific primers in our Standardized Expression Measurement (SEM) Center. The SEM Center uses high throughput, automated equipment and proprietary software that enables file-based experimentation ensuring all assays are setup, performed, and analyzed with little human intervention. All assays are performed 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). The SMIS contain competitive Internal Standards at precisely known quantities for each transcript to be measured and are added to the cDNA sample. Gene-specific primers are added to the cDNA and SMIS mixture and amplified by PCR. The amount of transcript for each gene in a sample is measured relative to its respective Internal Standard within the Standardized Mixture of Internal Standards (SMIS). These mixtures of Internal Standards allow for the simple calculation (no time consuming statistical analysis is needed) of numbers of molecules of transcripts for the target gene relative to a reference gene and to each other gene measured. All data are reported as a number of mRNA molecules for gene "X" per 10⁶ molecules of reference gene. If desired, these standardized numeric gene expression values can be easily normalized to any transcript that is measured through simple mathematical calculations. Since numerical values are determined, data from different samples and different experiments can be directly compared. See SEM Center GLP Services.

New Gene Assay Development for Internal Standards Products used in StaRT-PCR Gene Transcript Abundance Assays
Gene Express, Inc. recognizes that researchers require assays for a group of genes that are appropriate to their specific studies. For this reason, Gene Express' scientists will design robust, highly specific and sensitive StaRT-PCR gene assays based on the needs of the individual researcher. Gene Express' client proven StaRT-PCR multi-gene Transcript Abundance Measurement technology is designed to deliver standardized, reproducible quantitative measurement of multi-gene activity in a convenient and cost-effective manner. All assays are designed and developed under the FDA Good Laboratory Practice (GLP) regulations and in compliance with Gene Express' defined and tested SOPs (Standardized Operation Procedures). The 29-step assay development process is highly quality controlled (QC) with quality assurance (QA). See New StaRT-PCR Gene Assay Development.

Pharmacogenomics Consulting Services
Gene Express Technical expertise will assist your company in achieving its pharmacogenomics goals Utilizing StaRT-PCR that is a quantitative, standardized multi-gene expression method that meets the new regulatory guidelines provides the necessary technology to create successful outcomes. The use of Standardized Mixtures of Internal Standards (SMIS) provides the quality control that is required. StaRT-PCR provides standardized numerical gene expression values to associate transcript profiles with phenotypes. The StaRT-PCR technology provides researchers the tools and technology to develop clinically validated biomarker assays and Interactive Transcript Abundance Indices (ITAIs). Our extensive expertise in gene expression analysis will help researchers achieve new levels of scientific integrity and discovery. Please contact Gene Express today to discuss your needs - call 800-820-8341 or email

Technology Licenses
Gene Express, Inc. will consider a licensing arrangement for particular clients and/or strategic partners. The StaRT-PCR technology provides not only a distinct competitive advantage in the industry but provides precise data. The use of Standardized Mixtures of Internal Standards (SMIS) allows scientists to obtain standardized, quantitative, multi-gene Transcript Abundance data. This standardized data is critical for application to drug development, theranostics, prognostics, clinical biomarkers and molecular diagnostic products. Gene Express Inc will evaluate many different strategic and/or licensing arrangements that would add value to both parties. Licensing arrangements could include one or more of the following:

• Reagents and other data and/or material for the production of kits
• A full GLP SEM Center�
• Biomarkers
• Clinically Validated Biomarkers and Interactive Transcript Abundance Indices (ITAIs)
• StaRT-PCR Kits
• Patented reagents with Internal Standards and Standardized Mixtures of Internal Standards (SMIS)