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Transgenomic, Inc. (NASDAQ:TBIO), a global biotechnology company advancing personalized medicine in cardiology, oncology, and inherited diseases through advanced diagnostic tests and clinical and research services, today announced a research agreement with the University of Melbourne to conduct additional clinical validation studies of its Multiplexed ICE COLD-PCR^TM (MX-ICP) technology. MX-ICP is a high sensitivity DNA amplification technology that allows the simultaneous detection of multiple mutations in multiple genes from tumor samples or any liquid sample, such as blood or urine.

MX-ICP can enable identification of known and unknown genetic mutations at limit of detection levels (LOD) of 0.01%, which is far more sensitive than the 5% LOD achieved by next-generation sequencing (NGS) alone and the 20% LOD achieved by Sanger sequencing. Previous studies have suggested that this ultra-high sensitivity makes it possible to analyze DNA shed by tumors into the patient’s circulation, eliminating the need to use tissue from invasive and costly tumor biopsies for the DNA analyses needed to serially monitor disease progression and therapeutic benefit in personalized cancer therapy. What is not resolved is whether the ultra-high sensitivity achievable with the MX-ICP reveals clinically-relevant new information compared to using NGS technology alone.

The new study will be conducted using DNA isolated from pre-treatment tumor biopsies from patients enrolled in clinical trials. It aims to determine the prevalence and clinical significance of ultra-low frequency mutations that would otherwise go undetected by NGS or Sanger sequencing-based methodologies. In the next phase of the project, Transgenomic expects to conduct further studies with University of Melbourne researchers to validate the use of MX-ICP to accurately detect tumor mutations using blood or plasma.

The MX-ICP study will be conducted by researchers at the University of Melbourne under the direction of Professor 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. Professor Waring is well-known for his work in translational pathology in both academia and industry, and earlier in his career was Director of Pathology at the Peter MacCallum Cancer Centre in Melbourne and Senior Director of Pathology and Diagnostics at Genentech Inc.

Paul Kinnon, President and Chief Executive Officer of Transgenomic commented, “We are honored to collaborate with Paul Waring, a leader in molecular pathology, and his team at the University of Melbourne to assess the clinical importance of the ultra-high LOD achievable with MX-ICP and to evaluate its potential to enable personalized cancer therapy. Paul’s deep interest in translational research, his access to patient samples and his extensive clinical and industry experience should be invaluable as we develop and commercialize this exciting technology.”

Professor Waring noted, “New amplification technologies such as MX-ICP, when combined with advances in sequencing, provide an opportunity to understand the clinical significance of ultra-low frequency mutations and to use them to molecularly monitor patients with cancer. Transgenomic’s MX-ICP technology, with its ability to achieve the study’s targeted sensitivity of 0.02% LOD and to be performed in any diagnostic laboratory on any NGS platform, will help advance liquid biopsies into routine clinical practice. We look forward to working with our colleagues at Transgenomic to evaluate the utility of their technology in the clinic.”

Transgenomic’s MX ICE COLD-PCR technology is exclusively licensed from the Dana-Farber Cancer Institute.

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.