SOURCE: Gene Express, Inc.

September 27, 2007 08:30 ET

Gene Express Lung Cancer Diagnostic Demonstrates 96% Accuracy in Study

TOLEDO, OH--(Marketwire - September 27, 2007) - Gene Express, Inc. today announced that its molecular diagnostic test for lung cancer has demonstrated high levels of accuracy in a recent study presented at the American Association for Cancer Research's second International Conference on Molecular Diagnostics in Cancer Therapeutic Development.

James C. Willey, M.D., Founder, Inventor and Chief Science and Medical Consultant to Gene Express, and his colleagues from the University of Toledo, identified a panel of 15 genes that could serve to predict cancer.

According to Dr. Willey, a test for these genes, in normal cells sampled via bronchoscopy, could serve as a technique to identify those individuals genetically at risk for lung cancer. In a study of 49 subjects, Dr. Willey and his colleagues were able to correctly identify the individuals with cancer 96% of the time.

To determine which genes are active in lung cancer, Dr. Willey and his colleagues utilized Gene Express's proprietary and patented StaRT-PCR™ (Standardized Reverse Transcription Polymerase Chain Reaction) platform technology for measuring messenger RNA (mRNA) transcripts levels of the 15 genes.

Previously, the researchers had published findings demonstrating that genes responsible for protecting lung cells from damage caused by cigarette smoke or environmental toxins are sub-optimally regulated in the normal lung cells of individuals who develop lung cancer. In this study, Dr. Willey and his colleagues put their theories to the clinical test by measuring transcript abundance (TA) of 15 genes that encode protective antioxidant and DNA repair proteins in lung airway cells taken from 25 people with lung cancer and 24 people without the disease.

Their previous research allowed them to determine the threshold levels of TA for each gene -- the point at which the amount of mRNA transcripts would indicate a tendency toward cancer. In this study, they used the threshold levels as a basis to assign a value of one or zero to each of the targeted genes for an individual subject, with "zero" indicating normal TA.

If the sum total of a subject's target genes was greater than or equal to seven, the genes could collectively serve as a biomarker for lung cancer, the researchers found. Their results yielded one false negative and seven false positives among the 49 individuals assessed. According to Dr. Willey, they believe that a positive result in a subject without lung cancer may not actually be false positive, but rather could mean that the person is at an increased risk for lung cancer, which might arise later.

These results justify a larger, prospective study to determine whether this biomarker will be useful in predicting risk for lung cancer in current and former smokers. "Overall, the study showed a high degree of accuracy for picking out lung cancer patients," said Dr. Willey.

Chief Executive Officer of Gene Express, Gerald Vardzel commented, "We are excited about these results, as they demonstrate the value of our platform technology in the development of molecular diagnostics and the movement towards personalized medicine. Our plan is to further develop this lung cancer test according to FDA requirements for ultimate commercialization. This is an example of Gene Express's potential to impact drug development and create new patient treatment paradigms through our ability to identify and develop clinically valid biomarkers with absolute measurement of gene expression."

About Gene Express, Inc.

Gene Express, Inc. accelerates and enables drug and molecular diagnostic development by providing standardized genomic data. The Company's proprietary and patented StaRT-PCR™ (Standardized Reverse Transcription Polymerase Chain Reaction) platform technology for measuring gene expression levels in cells, clinical biopsies and blood is being used by numerous pharmaceutical concerns, as well as leading academic centers. The Company's $3 billion focus market for licensing and contract services includes the drug development, academic and molecular diagnostics segments. Additional information is available on the Company's website at www.geneexpressinc.com.

Any forecasts, plans, projections and other information contained in this press release describing events or results that may occur in the future are "forward-looking statements" as defined in the United States Private Securities litigation Reform Act of 1995. Forward-looking statements are subject to risks, uncertainties and important factors that are beyond the control of the Company that could cause actual results and events to differ materially from the results presently anticipated or projected. Readers are cautioned not to place undue reliance on these forward-looking statements and any such forward-looking statements are qualified in their entirety by reference to this cautionary statement. All forward-looking statements contained herein speak only as of the date of this release and are based on current expectations. The Company disclaims any obligation to update or revise any forward-looking statements.

Contact Information

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