Transgenomic Launches New Multiplexed ICE-COLD PCR™ Service in Biomarker Identification Business

Multiplexed ICE-COLD PCR a Benchmark for Accuracy and Sensitivity in Mutation Detection across the Entire Development Spectrum through Clinical Trials

Visit us at 2015 AACR Annual Meeting, Booth 2149

OMAHA, Neb.--(BUSINESS WIRE)--Transgenomic, Inc. (NASDAQ:TBIO) today announced that its groundbreaking Multiplexed ICE COLD PCR™ (MX-ICP) technology is now available to pharmaceutical and biotechnology customers of the company’s Biomarker Identification business unit. MX-ICP is an ultra-high sensitivity DNA amplification technology that allows the detection of multiple mutations in multiple genes from any sample, either from a tumor biopsy or from liquids such as blood or urine. MX-ICP is validated and available for use on all sequencing platforms.

“With our validation studies now complete, we are delighted to offer Multiplexed ICE-COLD PCR to our Biomarker Identification service customers”

“With our validation studies now complete, we are delighted to offer Multiplexed ICE-COLD PCR to our Biomarker Identification service customers,” said Paul Kinnon, President and Chief Executive Officer of Transgenomic. “MX-ICP provides unique advantages for biomarker discovery and development. Firstly, it permits detection of mutations down to 0.01% frequency. This 100-fold or greater improvement to the level of detection limits of existing sequencing methods, allows clinically relevant mutations to be identified not only in tumor tissue but in less invasive sample types, such as plasma and urine. Secondly, tests incorporating MX-ICP can enable less invasive procedures for patients while providing more clinically relevant data to physicians., Also, the recently added quantification capabilities, provides our customers and partners a competitive edge by streamlining and improving the process from discovery up through clinical validation. Finally, MX-ICP can be easily run on any NGS or digital PCR platform, meaning it can be incorporated into our clients’ existing workflows from research to clinical use. And, our scientists and staff have extensive experience across the entire development spectrum and can provide support across all areas of biomarker development.”

Mr. Kinnon continued, “This launch is the first stage of our commercialization roadmap for MX-ICP and represents an important milestone for Transgenomic. It will be followed in the coming months by the introduction of our MX-ICP kits for Research Use in the U.S. and our CE-marked kits for clinical or in vitro diagnostic use in the E.U. As announced, we also are working to establish multiple strategic partnering and licensing relationships with sequencing platform and other life science companies.”

Transgenomic’s proprietary Multiplexed ICE-COLD PCR offers valuable advantages for the sensitive detection of low level genetic alterations. It delivers at least a 100-fold improvement in sensitivity compared to standard methodologies and enriches multiple common and uncommon alterations in any gene using a single assay. The ultra-high sensitivity of MX-ICP makes it feasible to conduct comprehensive genomic analyses using either tissue or liquid biopsies. MX-ICP is platform agnostic and compatible with all current sequencing platforms, from Sanger sequencing to droplet digital PCR systems and ultra-high throughput NGS systems. MX-ICP is robust, easy to use, and is easily implemented with minimal changes to established sequencing workflows. Transgenomic recently added quantification capabilities to the technology, further extending its utility for cancer patient monitoring.

Transgenomic representatives are available at Booth 2149 at AACR 2015, and company scientists are presenting a poster on Multiplexed ICE-COLD PCR on April 22, 2015 between 8:00am and noon:

• Poster 5438: Multiplexed ICE COLD-PCR coupled to NGS and ddPCR enables enhanced detection of low-level DNA mutations in tissues and liquid biopsies, Section 31, Poster Board Number 20

For more information on Transgenomic and its Biomarker Identification services, click here.

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^TM 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. 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.