TOLEDO, OH -- 09/27/07 --
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(TM)
(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(TM) (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:
Rachel Levine
The Global Consulting Group
Tel: 646-284-9439
E: Email Contact
