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Transgenomic Launches Ultra-High Sensitive ICEme ™ Mutation Enrichment Kits Enabling Turbocharged Cancer Research on Existing Platforms

2015-07-01 07:40 ET - News Release

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.

Contacts:

Media Contact
BLL Partners LLC
Barbara Lindheim, 212-584-2276
blindheim@bllbiopartners.com
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Investor Contact
Argot Partners
Susan Kim, 212-600-1902
susan@argotpartners.com

Source: Transgenomic, Inc.

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