SOURCE: Gene Express, Inc.

August 11, 2008 10:35 ET

Gene Express Announces Licensing Agreement With NeoGenomics Laboratories

Companies Establish Key Partnership for Validation and Commercialization Purposes

WILMINGTON, NC--(Marketwire - August 11, 2008) - Gene Express, Inc. today announced that it has signed three definitive agreements with NeoGenomics Laboratories to license the SEM Center and StaRT-PCR™ (Standardized Reverse Transcription Polymerase Chain Reaction) Technology. NeoGenomics will support Gene Express in its FDA validation of its Lung Cancer Risk Prediction and BCR/ABL tests. The agreements will also allow NeoGenomics to commercialize Gene Express diagnostic tests, validate future Gene Express technology to fulfill FDA requirements, and utilize StaRT-PCR for their own commercial activities. These agreements succeed in establishing a key validation and commercialization partnership between Gene Express and NeoGenomics.

Jonathan D. Rowe, Ph.D., Senior Vice President of Strategy and Clinical Innovation for Gene Express, stated, "NeoGenomics provides significant experience and insight in the field of clinical molecular diagnostics as well as new assay validation, clinical trials and FDA submissions which are of great value to Gene Express. This partnership allows Gene Express to fully develop and execute its innovative pipeline with a skilled partner that is able to provide comprehensive support from validation through to commercialization of our products."

Robert Gasparini, President and Chief Scientific Officer for NeoGenomics, stated, "Gene Express has developed advanced and innovative technologies to support the diagnosis, prognosis and therapeutic response monitoring of disease. NeoGenomics, through its Clinical Trials Services division is excited to provide our expert assay validation, development and FDA submission services to Gene Express for their Lung Cancer Risk Prediction, BCR/ABL and pipeline products. This collaboration also reaffirms NeoGenomics' commitment to providing cutting edge diagnostic testing services to the medical pathology and oncology communities."

Over the next year, Gene Express will be undertaking activities to develop these genetic tests and bring them to market. Such activities will include: clinical trials to validate the lung cancer risk prediction test, submission of the data to the FDA, manufacturing of a regulatory compliant standard mixture of internal standards (SMIS) for the testing of BCR/ABL gene expression, clinical trials to validate the SMIS, and clinical trials to support a regulatory approved molecular diagnostic with internal standards for BCR/ABL.

Gene Express intends to complete the clinical validation and submission for FDA approval of the Lung Cancer Risk Prediction test in 4Q 2008, and will begin clinical trials to support an FDA approved BCR/ABL test by 1Q 2009.

About NeoGenomics Laboratories

NeoGenomics Laboratories is a high-complexity CLIA-certified clinical reference laboratory specializing in providing cancer genetics diagnostic testing, the fastest growing segment of the laboratory industry, to the Medical, Pharmaceutical and Diagnostic development industries. The company's testing services include cytogenetics, fluorescence in-situ hybridization (FISH), flow cytometry, morphology studies, anatomic pathology and molecular genetics. With business headquarters and their East Coast laboratory in Fort Myers, FL, and Clinical Trials Services and Research and Development departments operating out of their West Coast laboratory in Irvine, CA, NeoGenomics services the needs of pathologists, oncologists, urologists, hospitals, pharmaceutical and biotech companies, and Clinical Research Organizations throughout the United States. For additional information about NeoGenomics, visit

About Gene Express, Inc.

Gene Express, Inc. integrates personalized medicine into clinical care by enabling the generation of standardized, comparable and quality controlled data for molecular diagnostic testing. 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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