Commercial Agreement for Australia Allows University of Melbourne to use Transgenomic’s Multiplexed ICE COLD-PCR™ Product for Cancer Diagnostics and Biomarker Identification Services

OMAHA, Neb. (September 17, 2015) — Transgenomic, Inc. (NASDAQ: TBIO), today announced that it has granted a license to the University of Melbourne to use its Multiplexed ICE COLD-PCR™ (MX-ICP) technology for a number of research and clinical applications. MX-ICP is a high sensitivity DNA amplification technology that allows the detection of mutations in multiple genes from either tumors or any liquid sample, such as blood or urine. The first commercial license follows a 2014 research agreement between Transgenomic and the University of Melbourne for the conduct of clinical validation studies of the MX-ICP technology.

Under the terms of the new agreement, Melbourne University receives an exclusive license in Australia to Transgenomic’s new EGFR liquid biopsy cancer assays. The four licensed tests detect specific actionable mutations associated with sensitivity or resistance to targeted drugs used for colorectal and non-small cell lung cancer in many sample types but mainly in blood/plasma. The assays are highly accurate and provide precision detection levels down to as low as 0.01% from small amounts of blood or tissue samples. They will be available to researchers and also for diagnostic use through Melbourne University’s National Association of Testing Authorities (NATA) certified laboratory. Transgenomic will sell the EGFR kits to the University and will also receive royalties. In addition, Transgenomic will partner with Melbourne University to provide Biomarker Identification services to biopharmaceutical companies.

Prof. Paul Waring, Chair of Pathology at the University of Melbourne, Head of Molecular Pathology at Melbourne Health and Director of the Centre for Translational Pathology at Melbourne University, commented, “We have been working with the MX-ICP liquid biopsy technology for about a year and have been very favorably impressed with its accuracy, exceptional sensitivity and overall utility. We are delighted we will now be able to put it to work for our cancer patients and, in partnership with Transgenomic, to drug developers here in Australia.”

Paul Kinnon, President and Chief Executive Officer of Transgenomic, noted “The University of Melbourne and Prof. Waring are recognized leaders in molecular pathology and cancer genomics, so we are especially pleased to award this first commercial MX-ICP license to them for use in Australia. Melbourne University is an innovator in patient care and cancer treatment, and the agreement has the added benefit of providing us with the opportunity for additional validation of our MX-ICP technology and our new liquid biopsy diagnostic assays in partnership with a top tier cancer institution. This is the first of what we expect to be many licenses worldwide for our MX-ICP technology.”

Multiplexed ICE COLD-PCR achieves its ultra-high sensitivity through selective amplification of mutant DNA. 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 0.01% from plasma samples as small as 4 ml, making it possible to obtain accurate and sensitive detection of mutations using either liquid or solid tissue specimens.

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.

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™ and its unique genetic tests provided through its Patient Testing business. The company 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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