Three-Year Renewable Agreement Also Includes Non-Exclusive License to ICP in Canada

New Patent Has Issued Covering ICE COLD-PCR Technology in Canada                      

OMAHA, Neb. (January 12, 2017) — Transgenomic, Inc. (TBIO) (NASDAQ: TBIO), today announced a licensing agreement with leading Canadian laboratory services provider LifeLabs, which has selected Transgenomic’s ICE COLD-PCR (ICP) technology as its mutation enrichment platform for cancer testing. The three-year, renewable agreement includes a non-exclusive license to the ICP technology in Canada. Separately, Transgenomic also announced issuance of a new Canadian patent for ICP.

“LifeLabs is among the largest laboratory service providers in North America, and we view their adoption of ICE COLD-PCR as a key validation of both the technology and our commercial model that focuses on licensing to a wide variety of molecular diagnostics partners worldwide,” commented Paul Kinnon, President and Chief Executive Officer of Transgenomic. “We believe that this sizable commercial licensing agreement is indicative of the growing traction in the marketplace we have been anticipating, and we believe that it will be followed by additional significant ICP agreements going forward.”

LifeLabs intends to use ICE COLD-PCR with tissue samples and is receiving a non-exclusive license to the ICP technology in Canada. The three-year renewable agreement also allows LifeLabs to benefit from technology improvements and additional product launches during its term.

“As the largest laboratory service provider in Canada, LifeLabs is committed to offering our customers access to advanced clinical genomic analyses made possible by major new technologies such as ICE COLD-PCR,” said Joby McKenzie, Senior Vice President, Business Development of LifeLabs. “We anticipate that this flexible, versatile mutation enrichment technology will be applied to other molecular testing applications as adoption of genomic and precision medicine expands.”

Recently-issued Canadian Patent No. 2792433, Full Cold-PCR Enrichment with Reference Blocking Sequence, covers the use of the ICE COLD-PCR method that enriches mutated DNA sequences in a background of normal DNA through to 2030. This method can be applied to the analysis of very low quantities of circulating tumor DNA found in a patient’s blood.

Transgenomic’s ICE COLD-PCR technology delivers up to a 500-fold increase in mutation detection compared to most current methods, with levels of detection routinely achievable down to 0.01%. This ultra-high sensitivity enables detection of low level mutations that allow accurate patient monitoring as well as stratification of cancer sub-populations. ICP works well with most patient samples, including tissue, blood, plasma, urine and other biofluids and it is compatible with most of the downstream genomic analytic platforms commonly available in laboratories today.

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

About LifeLabs 

LifeLabs is a Canadian-owned company with over 50 years of experience providing laboratory testing services to help health care providers diagnose, treat, monitor and prevent disease in patients. In communities across British Columbia and Ontario, LifeLabs delivers cost-effective, convenient access to laboratory testing services essential for optimal outcomes in health care. LifeLabs employs over 5,000 professionally trained staff and delivers over 100 million laboratory tests, supporting over 19 million patient visits annually. In 2013, LifeLabs acquired BC Biomedical in British Columbia and CML HealthCare in Ontario, making LifeLabs the largest community laboratory in Canada. LifeLabs is indirectly owned by OMERS Administration Corporation, whose interest is managed by Borealis Infrastructure.

About Transgenomic

Transgenomic, Inc. is a global biotechnology company advancing personalized medicine in oncology and inherited diseases through advanced diagnostic technologies, such as its revolutionary ICE COLD-PCR, which enables use of liquid biopsies for mutation detection. The company also provides specialized clinical and research services to biopharmaceutical companies developing targeted therapies. 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 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, expectations regarding new clients, projects and prospects, and MX-ICP’s ability to accelerate the Company’s growth and generate revenue. 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.



Barbara Lindheim

BLL Partners



Transgenomic Investor Relations