SOURCE: Gene Express, Inc.

April 21, 2008 09:00 ET

Gene Express Announces Licensing Agreement With University of South Florida

Company to Develop Prognostic Test for the Detection and Treatment of Lung Cancer

TOLEDO, OH--(Marketwire - April 21, 2008) - Gene Express, Inc. today announced that it has signed an agreement with the Division of Patents & Licensing Research Office at the University of South Florida (USF) to license some of their gene expression technology necessary to develop prognostic tests for cisplatin and irinotecan chemoresistance.

The ability to assess patients for resistance to chemotherapeutics prior to chemotherapy would offer physicians an important tool in providing appropriate chemotherapy to patients afflicted with cancers of the lung and colon. Mechanisms of chemoresistance likely involve multiple gene products involved in DNA repair, drug uptake and other unspecified processes.

Some of the specific technology licensed includes the ERCC1 and RRM1 genes. Researchers at the University of South Florida have now discovered a correlation between expression of ERCC1 (excision repair cross-complementing-1) and the survival of patients with NSCLC. In addition, USF scientists have determined that ERCC1 activity is a significant and independent predictor of survival in patients with NSCLC. Researchers at Florida have also shown that RRM1 is a clinically important determinant of malignant behavior in NSCLC. They have determined that knowing the level of expression of this gene adds significant information to management decisions independent of the currently used outcome predictors of tumor stage, performance status, and weight loss.

Jonathan D. Rowe, Ph.D., Senior Vice President of Strategy and Clinical Innovation for Gene Express, stated, "By adding these genes to our growing collection of gene standards, we will be able to develop the most accurate, sensitive and reproducible molecular diagnostic tests for identifying tumors that are resistant to specific chemotherapeutics. The results obtained from such tests will be used by physicians to make appropriate treatment decisions. Ultimately, our goal is to facilitate the implementation of personalized medicine as a standard of practice in healthcare. In this instance, personalized therapy can be provided to cancer patients."

Over the next two years, Gene Express will be undertaking activities to develop this prognostic test and bring it to market. Such activities will include: manufacturing of a regulatory compliant standard mixture of internal standards (SMIS) for genes of interest for testing of cisplatin chemoresistance; development and approval of an Institutional Review Board (IRB) clinical protocol to collect patient samples from normal patients and patients with NSCLC in the absence and presence of treatment with cisplatin; and analytical method validation of cisplatin chemoresistant predictive genes by Standardized Reverse Transcription PCR (StaRT-PCR™ using SMIS™).

Gene Express intends to complete clinical validation for correlation of gene expression versus chemoresistance for cisplatin treatment by April 2009, and submit a 510K class II prognostic test for cisplatin resistance to the FDA by May 2009. The Company would then anticipate receiving FDA approval of the 510K medical prognostic test in August 2009 and commercial application completed by December 2009.

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

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.

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