Transgenomic, Inc. (OTCBB:TBIO), a global biotechnology company
advancing personalized medicine in cardiology, oncology, and inherited
diseases through diagnostic tests as well as clinical and research
services, today announced that the U.S. Patent and Trademark Office
(USPTO) has issued a new patent related to its licensed ICE COLD-PCR
technology. The patent, titled “Full cold-PCR enrichment with reference
blocking sequence”, was assigned U.S. Patent No. 8,623,603 and is set to
expire in 2031.
“This newly issued patent significantly strengthens our intellectual
property portfolio and further supports the ongoing development of this
cutting-edge technology that has the potential to revolutionize cancer
screening, diagnosis, monitoring, and treatment selection, as well as
replacing the need for biopsies and reducing this massive cost to the
healthcare system,” said Paul Kinnon, President and Chief Executive
Officer of Transgenomic. “We intend to leverage this proprietary asset
immediately in both our patient testing business and with our
pharmaceutical and biotechnology client companies, the primary market
for ICE COLD-PCR, especially those looking for low level mutations in
blood. A strong patent position is at the core of our business model and
strengthens our competitive advantage in the marketplace.”
The new U.S. patent extends the scope and longevity of the COLD-PCR
intellectual property portfolio. The '603 patent covers ICE COLD-PCR
methods for enriching low abundance alleles in nucleic acid samples. It
is directed in particular to the use of an excess amount of reference
blocking sequence in an amplification reaction mixture in order to
improve the enrichment efficiency, and reduce cycle time, of full
COLD-PCR. The new patent reinforces Transgenomic's ICE COLD-PCR
technology platform alongside its other high sensitivity mutation
detection technologies, such as SURVEYOR® Scan and BLOCker™-
Sequencing. Originally developed by the Makrigiorgos laboratory, the
'603 patent is owned by the Dana-Farber Cancer Institute and licensed to
Transgenomic.
About ICE COLD-PCR
ICE COLD-PCR (Improved and Complete Enrichment COamplification
at Lower Denaturation temperature) technology was
originally developed by the Dana-Farber Cancer Institute and is
supported by multiple validation studies confirming reproducible
mutation detection at very high sensitivity. It selectively amplifies
mutant DNA by exploiting differences in denaturation temperatures
between mutant/blocker DNA duplexes and wild-type (normal)/blocker DNA
duplexes. ICE COLD-PCR is able to detect mutant DNA occurring in as low
as 0.01% frequency in a majority of wild-type populations which results
in 100-400 fold improvements in detection limits. ICE COLD-PCR is ideal
for standard Sanger sequencing, next generation sequencing, digital PCR
and other technologies.
The ICE COLD-PCR technology is not specific to a single mutation within
a DNA target but enables detection of any mutation in a given region of
DNA. This approach allows clinicians to use small amounts of sample for
genetic analysis or non-invasive sample collection methods (e.g., a
blood draw) to enable detection of mutant DNA species present in serum
or plasma, circulating tumor cells, urine, or bronchial lavage
specimens. DNA can also be analyzed from fine needle aspirates,
core-biopsies, or directly from tumors. Since ICE COLD-PCR can detect
low level mutations in samples where an abundance of “normal” DNA
exists, such as blood, repeated assessments of a patient’s disease
status can be determined without having to take additional biopsies from
the tumor.
About Transgenomic, Inc.
Transgenomic, Inc. (www.transgenomic.com)
is a global biotechnology company advancing personalized medicine in
cardiology, oncology, and inherited diseases. The Company has three
complementary business units: Patient Testing, Biomarker Identification,
and Genetic Assays and Platforms, which provide specialized diagnostic
tests, contract research services for drug development, and equipment,
reagents and other consumables for clinical and research applications in
molecular testing and cytogenetics.
Forward-Looking Statements
Certain statements in this press release constitute “forward-looking
statements” of Transgenomic 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 Transgenomic's filings
with 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. All information in this press release
is as of the date of the release and Transgenomic does not undertake any
duty to update this information, including any forward-looking
statements, unless required by law.
Copyright Business Wire 2014