STTR Grant Supports Addition of Greater Multiplexing Capabilities to ICE COLD-PCR, an Advanced Technology that Enables Use of Tissue or Liquid Biopsy Samples and Provides Up to 500-Fold Increase in Mutation Detection on Any Sequencing Platform

OMAHA, Neb. (December 23, 2015) — Transgenomic, Inc. (NASDAQ: TBIO), a global biotechnology company advancing precision medicine through advanced diagnostic tests and clinical and research services, today announced that it has been awarded a two-year Small Business Technology Transfer (STTR) grant by the US National Institutes of Health (NIH). The $1.5 million grant will fund a collaborative project with the Dana-Farber Cancer Institute to augment the multiplexing capabilities of Transgenomic’s ICE COLD-PCR™ (ICP) technology. ICE COLD-PCR was originally developed by Dana-Farber, which has licensed exclusive worldwide rights to Transgenomic.

“We are delighted that the NIH has recognized the value of our validated ICE COLD-PCR as an important enabling technology for precision medicine by awarding this STTR Phase II grant to Transgenomic,” notes Paul Kinnon, President and CEO of Transgenomic. “While we currently offer multiplexing capability in our ICP-powered kits and services, this grant will enable Transgenomic and Dana-Farber to accelerate development of very highly multiplexed formats for applying ICP simultaneously to hundreds or thousands of targets. We expect this will pave the way for its wide adoption and use with cutting-edge high throughput sequencing platforms and whole genome panels. We believe that ICE COLD-PCR is a powerful enabling technology that has the potential to transform precision medicine into a practical part of routine medical care, and look forward to working with our colleagues at Dana-Farber to incorporate these significantly enhanced multiplexing capabilities into the technology.”

Mike Makrigiorgos, Professor of Radiation Oncology at Dana-Farber and Harvard Medical School, and principal investigator on the project for Dana-Farber, says: “The NIH/STTR funding will enable us to develop multiplexed formats for the COLD-PCR/ICE COLD-PCR technologies that filter out mutated DNA from within a high excess of normal DNA circulating in cancer patients’ blood. The enhanced technology will enable multiplexed mutation enrichment, which combines well with sequencing and is key to enabling rapid and reliable mutation detection that identifies and traces mutations that may cause drug resistance, indicate remaining tumor load or provide doctors with an early indication of relapse”.

The STTR program is designed to promote public/private sector partnerships that include joint venture opportunities for small businesses and not-for-profit research institutions. This new Phase II STTR grant follows successful completion of a Phase I ICE COLD-PCR grant awarded to Transgenomic and Dana-Farber in 2013.

ICE COLD-PCR is an enrichment technology used prior to sequencing that enhances DNA analyses by selectively amplifying only the mutated DNA that is useful for disease diagnosis, monitoring and treatment. ICP makes possible the detection of mutated DNA at very high sensitivity—up to a 500-fold increase in sensitivity compared to conventional approaches. The technology ensures that all mutations are identified, including rare mutations and new mutations that have not previously been detected. The ultra-high sensitivity of ICP also allows DNA testing to be done using either tissue or liquid biopsy samples, including blood, plasma and urine. ICP is easily integrated into current laboratory workflows and can be used with standard Sanger sequencing, next generation sequencing, digital PCR and other technologies.

ICE COLD-PCR was originally developed by the laboratory of Dr. Mike Makrigiorgos at the Dana-Farber Cancer Institute, which has exclusively licensed rights to the technology to Transgenomic.

For more information about Transgenomic’s ICE COLD-PCR products and services, visit transgenomic.com/technology/mx-icp/
About the Grant
The funding for this research award is supported by the National Cancer Institute of the National Institutes of Health under Award Number R42CA180389. The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About Transgenomic
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™ technology 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. 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.

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