SOURCE: Gene Express, Inc.
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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 www.neogenomics.org.
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
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.