Transgenomic Completes Licensing Option With Dana-Farber Cancer Institute on Cold-PCR...

Tue Apr 7, 2009 12:05pm EDT
 
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Transgenomic Completes Licensing Option With Dana-Farber Cancer Institute on
Cold-PCR for Enrichment of DNA Mutations

OMAHA, Neb., April 7 /PRNewswire-FirstCall/ -- Transgenomic, Inc. (OTC
Bulletin Board: TBIO), a leading global biotechnology company, announces that
it has completed a licensing option with the Dana-Farber Cancer Institute,
Boston, MA with regard to a method known as Cold-PCR.  This variation of the
standard PCR technology enriches mutations in samples where normal DNA
predominates. Cold-PCR was invented at Dana-Farber by Dr. Mike Makrigiorgos
who has demonstrated its effectiveness in enriching for mutations in
cancer-related genes in samples where DNA sequencing cannot detect very low
concentrations of somatic DNA mutation. 

"We are very excited to be able to work with Dana-Farber on continuing to
develop this technology.  Cold-PCR has the potential to further increase the
sensitivity of Transgenomic's WAVE DHPLC and Surveyor Nuclease products for
mutation detection in cancer and mitochondrial diseases," said Eric Kaldjian,
CSO at Transgenomic. "In combination, Cold-PCR and WAVE/Surveyor have the
potential to detect one mutant copy of DNA out of a thousand to as many as ten
thousand normal copies.  This will be particularly valuable in cancer-related
mutation detection of free DNA in blood and body fluids and in producing a
mutation profile of primary tumors to predict resistance to targeted
therapies.  It could also have application in analysis of mitochondrial DNA
heteroplasmies." 

"We are delighted to be able to develop jointly the application of Cold-PCR
with Transgenomic's existing technologies," said Dr. Mike Makrigiorgos,
Director of Medical Physics and Biophysics Division at Dana-Farber and an
associate Professor of Radiation Oncology at Harvard Medical School. "We
believe that coupling Cold-PCR with DHPLC and Surveyor Nuclease promises a
significant solution to high sensitivity detection of somatic mutations that
are key to cancer biology."

Cold-PCR will have applicability in detection of cancer-related mutations
where critical mutations are present at a very low percentage compared to
normal DNA. Examples would be in blood and urine or where the tissue collected
contains mostly normal cells. This would allow clinicians to use less
intrusive methods for genetic analysis or allow more efficient use of tumor
tissue samples. Additionally the method could enhance the detection of the
emergence of cancer-drug resistance mutations, allowing early detection of
relapse. 

Transgenomic CEO Craig Tuttle said: "We believe that Cold-PCR is an important
addition to our high-sensitivity mutation detection portfolio of cutting edge
technologies. It will allow us to continue to be able to offer affordable,
state-of-the-art solutions to challenging areas of genetic analysis such as
early detection of cancer development, drug resistance and relapse as well as
expanding our mitochondrial DNA toolbox."

Technical Information
When mutant and reference DNA samples from the same gene are mixed and
re-annealed, variations between these sequences cause double-stranded DNA
heteroduplexes to form.  The WAVE System employs denaturing HPLC to separate
these homo- and hetero-duplexes by ion-pairing reverse-phase HPLC. This
technology has been in widespread use for genomic analysis being cited in over
2000 peer-reviewed publications. As an alternative offering, Transgenomic's
SURVEYOR Nuclease cleaves such heteroduplexes with high specificity at sites
of base mismatch or small insertions/deletions. It has a proven track record
as a robust and reliable tool in analyzing DNA variations, especially where
the mutant alleles are at a very low concentration within the sample (less
than 1% of the total wild type allele concentration). Cold-PCR protocols
preferentially amplify heteroduplexes such that mutant alleles become enriched
compared to normal alleles.  The range of enrichment demonstrated to date
varies from 3 to 100-fold, which will contribute to Transgenomic's target of
achieving a 1/10,000 mutant to normal allele ratio detection in a routine,
cost-effective and high throughput protocol. This level of detection will
allow straightforward tumor analysis via surrogate tissues such as blood and
urine.

About Transgenomic
Transgenomic is a global biotechnology company that provides unique products
and services for automated high sensitivity genetic variation and mutation
analysis. Their offerings include systems, products, discovery and laboratory
testing services to the academic and medical research, clinical laboratory and
pharmaceutical markets in the fields of Pharmacogenomics and personalized
medicine. Specific offerings include WAVE(R) DHPLC Systems, related
consumables and assay kits, Cytogenetics automated systems, and Transgenomic
Pharmacogenomics and Reference Laboratory Services. Transgenomic
Pharmacogenomics and Laboratory Services utilize their technology and
expertise to provide a menu of mutation scanning tests for over 700
cancer-associated genes and more than 60 validated diagnostic tests to meet
the needs of pharmaceutical and biotech companies, research and clinical
laboratories, physicians and patients. For more information about the
innovative systems, products and services offered by Transgenomic, please
visit: www.transgenomic.com.

Cautionary Statements
Certain statements in this press release constitute "forward-looking
statements" within the meaning of the Private Securities Litigation Reform Act
of 1995, which involve known and unknown risks, uncertainties and other
factors that may cause actual results to be materially different from any
future results, performance or achievements expressed or implied by such
statements. Forward-looking statements include, but are not limited to, those
with respect to management's current views and estimates of future economic
circumstances, industry conditions, company performance and financial results,
including the ability of the Company to grow its involvement in the diagnostic
products and services markets. The known risks, uncertainties and other
factors affecting these forward-looking statements are described from time to
time in reports to the Securities and Exchange Commission. Any change in such
factors, risks and uncertainties may cause the actual results, events and
performance to differ materially from those referred to in such statements.
Accordingly, the company claims the protection of the safe harbor for
forward-looking statements contained in the Private Securities Litigation
Reform Act of 1995 with respect to all statements contained in this press
release.



SOURCE  Transgenomic, Inc.

Debra Schneider, Chief Financial Officer of Transgenomic, Inc.,
+1-402-452-5400, investorrelations@transgenomic.com

 

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