Multiplexed ICE COLD-PCR™ Technology Enables Use of Tissue or Liquid
Biopsy Samples and Provides Up to 500-Fold Increase in Mutation
Detection with LOD to 0.01%
Customizable Kits Work on All Platforms – Initial Menu Offers 17
Clinically Actionable Exons/Mutations for Use as Single Mutations or in
Combination
Company Website:
http://www.transgenomic.com
OMAHA, Neb. -- (Business Wire)
Transgenomic, Inc. (NASDAQ:TBIO), a global biotechnology company
advancing precision medicine through advanced diagnostic tests and
clinical and research services, today announced that its ICEme™ Mutation
Enrichment Kits for cancer research are now commercially available to
researchers worldwide. The kits, which were launched on June 30, 2015,
are based on Transgenomic’s Multiplexed ICE COLD-PCR™ (MX-ICP)
technology.
“The rapidly expanding focus on targeted and precision cancer therapies
makes this an ideal time to launch our ICEme research kits based on our
Multiplexed ICE COLD-PCR technology,” said Paul Kinnon, President and
Chief Executive Officer of Transgenomic. “These kits allow researchers
to supercharge the sequencing platforms already present in their labs,
including Sanger, NGS and dd PCR, to achieve greatly improved
detection--up to a 500-fold increase--simply by adding the ICEme Kits to
their current workflow. The unsurpassed sensitivity of the ICEme Kits
also means they can be used with most types of patient samples,
including plasma and urine.”
Mr. Kinnon continued, “We are launching with a menu of 17 mutations that
are of clinical relevance in major cancers, and we will be adding more
mutations on an ongoing basis. We also have introduced a new commercial website
that will make it easy for scientists around the globe to order and
obtain ICEme Kits, which they can easily customize with combinations of
mutations to meet their specific research needs. We believe this launch
marks an important milestone for Transgenomic that will help accelerate
the rapid advances now possible in the battle against cancer.”
ICEme Mutation Enrichment Kits leverage the distinctive performance
attributes of MX-ICP technology to help cancer researchers accelerate
the discovery of biomarkers, aid cancer research and eventually improve
cancer patient diagnosis and treatment. The kits work well with
virtually any type of patient sample, including tissue, blood, plasma,
urine and other biofluids. MX-ICP technology is also non-allele
specific, amplifying all mutations in the region under investigation. It
delivers ultra-high sensitivity, providing up to a 500-fold increase in
mutation detection compared to most current methods, with levels of
detection routinely achievable down to 0.01%.
The ICEme Kits are simple to implement and they work on most of the
analytic platforms commonly used in research laboratories today, fitting
into standard PCR workflows. The kits are easily customizable for use
with either single mutations or in combination--researchers can select
the mutations they want. The initial menu includes 17 clinically
relevant, actionable mutations that are associated with important
cancers such as colorectal, lung and breast cancer, and melanoma.
Additional mutations will be added on an ongoing basis.
Multiplexed ICE COLD-PCR was discovered in the laboratory of Dr. Mike
Makrigiorgos at the Dana-Farber Cancer Institute, which has exclusively
licensed rights to the technology to Transgenomic. Dr. Makrigiorgos
commented, “When we discovered this remarkable technology, we hoped that
its very high sensitivity, broad applicability and simplicity would
enable cancer researchers everywhere to better understand how tumor
mutations impact the disease, with the goal of accelerating the
development of more effective treatments. With the commercial launch of
the Transgenomic ICEme Kits, Multiplexed ICE COLD-PCR technology is
available to researchers around the globe, and we are very pleased that
its promise can now be fulfilled.”
ICEme Kits are currently available for mutations in a number of
important cancer-related genes including BRAF, EGFR, KRAS, NRAS &
PIK3CA, which are routinely studied for research on colorectal,
non-small cell lung (NSCLC) and breast cancer, as well as melanoma. The
ultra-high sensitivity of the kits allows researchers to robustly detect
low level mutations and stratify sub-populations for research projects.
Multiplexed ICE COLD-PCR technology preferentially enriches mutant DNA
sequences in an excess of wild-type DNA through selective amplification
of the mutant DNA. It amplifies all mutations in the region under
investigation, while suppressing wild-type alleles. The result is up to
a 500-fold increase in sensitivity in identifying mutations with the
most precise sequence alteration detection rates available--down to .01%
of the total DNA in the sample.
ICEme mutation enrichment kits can be used with DNA isolated from any
sample type including liquid biopsies such as plasma, urine, and
cerebrospinal fluid, as well as from tissues, including fresh, frozen,
FFPE and fine needle aspiration. ICEme Kits are suitable for use with
any currently used downstream sequence analysis platform and are easy to
implement by a simple modification of standard PCR protocols.
The ICEme kits have a number of formats, allowing flexibility over the
number of exons and reactions selected for the desired sample analysis.
Additional product information and protocols are available at www.transgenomic.com/products/iceme-kits-overview/.
Transgenomic,
Inc. is a global biotechnology company advancing personalized
medicine in cardiology, oncology, and inherited diseases through
advanced diagnostic technologies, such as its revolutionary ICE
COLD-PCR™ and its unique genetic tests provided through its Patient
Testing business. Transgenomic also provides specialized clinical and
research services to biopharmaceutical companies developing targeted
therapies and sells equipment, reagents and other consumables for
applications in molecular testing and cytogenetics. Transgenomic’s
diagnostic technologies are designed to improve medical diagnoses and
patient outcomes.
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 the
expected timing for the availability of additional mutations with the
ICEme kits, the potential uses for the ICEme kits, the effectiveness of
the ICEme kits and Multiplexed ICE COLD-PCR technology, the availability
of the ICEme kits for diagnostic use and expectations regarding the
ICEme kits’ and Multiplexed ICE COLD-PCR’s ability to facilitate the
development of Transgenomic’s pipeline. 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, including in Transgenomic’s Annual
Report on Form 10-K, filed with the Securities and Exchange Commission
on April 15, 2015. 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150701005548/en/
Contacts:
Media Contact
BLL Partners LLC
Barbara Lindheim,
212-584-2276
blindheim@bllbiopartners.com
or
Investor
Contact
Argot Partners
Susan Kim, 212-600-1902
susan@argotpartners.com
Source: Transgenomic, Inc.
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