Transgenomic, Inc. Establishes Clinical-Commercial Advisory Board To Help Optimize Use Of Multiplexed ICE COLD-PCR In Oncology

OMAHA, Neb.--(BUSINESS WIRE)--Transgenomic, Inc. (NASDAQ: TBIO) today announced that it has established a Clinical-Commercial Advisory Board (CCAB) for oncology applications of its Multiplexed ICE COLD-PCR^TM (MX-ICP) technology. The CCAB is headed by Dr. Scott Patterson, a recognized expert in the application of genetic biomarkers to cancer drug development. Also joining as inaugural CCAB members are Dr. Bruce E. Johnson, Chief Clinical Research Officer at the Dana-Farber Cancer Institute and molecular pathologist Professor Paul Waring of the University of Melbourne, who is a pioneer in the application of genomic technology to cancer diagnostics and drug development. Additional CCAB members are expected to be announced soon.

“The unmatched sensitivity, versatility and ease of use of our Multiplexed ICE COLD-PCR technology make it potentially valuable in a broad range of oncology applications, so we are looking to the CCAB to provide guidance on priorities for clinical and commercial development”

“The unmatched sensitivity, versatility and ease of use of our Multiplexed ICE COLD-PCR technology make it potentially valuable in a broad range of oncology applications, so we are looking to the CCAB to provide guidance on priorities for clinical and commercial development,” said Paul Kinnon, President and CEO of Transgenomic. “These distinguished founding members and others soon to be named will bring academic, medical and industry insight to the question of where MX-ICP can have the most impact on clinical outcomes. We expect they will help us identify which products and services should be developed and commercialized for which conditions and in which markets, as well as the optimal timing/phasing. We believe that the outstanding backgrounds of our founding members reflect the unique potential of this exciting technology.”

Scott Patterson, PhD, is Vice President, Biomarker Sciences in the R&D organization at Gilead Sciences, Inc, where he is responsible for development and implementation of biomarker and diagnostic strategies across all the company’s therapeutic areas. Previously, he was Executive Director, Medical Sciences at Amgen, Inc, where he established the company’s biomarker strategy and led the In Vitro Diagnostics Group from its inception. Prior to Amgen, Dr. Patterson was Vice President, Proteomics at Celera Genomics. Earlier in his career, he held research appointments at Amgen and at Cold Spring Harbor Laboratory, New York. Dr. Patterson received BSc and PhD degrees from The University of Queensland in Australia.

Bruce E. Johnson, MD, is Chief Clinical Research Officer, Dana-Farber Cancer Institute (DCFI) and Professor of Medicine, Harvard Medical School. He directs the Dana-Farber/Harvard Cancer Center Lung Cancer Program and his current research centers on the impact of genomic changes on the targeted treatment of thoracic malignancies. Earlier, Dr. Johnson was a researcher at the National Cancer Institute (NCI), where he headed the Lung Cancer Biology Section. Dr. Johnson was formerly on the ASCO Board of Directors and received the ASCO Cancer Foundation’s Translational Research Professorship for 2008-2013. In 2009, he won the International Association for the Study of Lung Cancer Scientific Award and was one of the Leaders of the AACR Team Science Award in 2010. Dr. Johnson is the author of more than 250 articles, chapters, reviews, and editorials. He completed his undergraduate studies at Harvard and received an MD degree from the University of Minnesota. Dr. Johnson’s postgraduate training was at the University of Chicago and the NCI.

Paul Waring MD, PhD, is the Chair of Pathology and Director of the Centre for Translational Pathology at the University of Melbourne in Australia, and Head of Molecular Pathology at Melbourne Health. Professor Waring is well-known for his work in translational pathology in both academia and industry. Earlier in his career he was Director of Pathology at the Peter MacCallum Cancer Centre in Melbourne and Senior Director of Pathology and Diagnostics at Genentech Inc. in California. Professor Waring trained as an anatomical pathologist at the University of Western Australia. He completed a PhD at the Walter and Eliza Hall Institute of Medical Research and a Fellowship at Stanford University.

Transgenomic’s proprietary Multiplexed ICE COLD-PCR was developed for the sensitive detection of low level genetic alterations. It is designed to help cancer researchers accelerate the discovery of biomarkers, aid cancer research and improve cancer patient diagnosis and treatment. The technology works well with virtually any type of patient sample, including tissue, blood, plasma, urine and other biofluids. Its ultra-high sensitivity routinely achieves levels of detection down to 0.01%, delivering at least a 100-fold improvement in sensitivity compared to standard methodologies and enriching multiple common and uncommon alterations in any gene using a single assay. MX-ICP is compatible with all current sequencing platforms. It is robust, easy to use, and is easily implemented with minimal changes to established sequencing workflows. Transgenomic has recently added quantification capabilities to the technology, further extending its utility for cancer patient monitoring.

Transgenomic recently launched its ICEme^TM Mutation Enrichment Kits for cancer researchers worldwide. MX-ICP technology is also available to pharmaceutical and biotechnology customers of the company’s Biomarker Identification business unit.

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.

For more information on currently available Multiplexed ICE COLD-PCR products and services, visit http://www.transgenomic.com/technology/mx-icp/

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. 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.