Transgenomic signs license with Dana-Farber to develop multiplexed ICE COLD-PCR technology

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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 that it has signed a license with the Dana-Farber Cancer Institute for worldwide rights to develop and commercialize multiplexed versions of its ICE COLD-PCRTM technology (MX ICE COLD-PCR).

The new license is exclusive to Transgenomic and expands the current relationship with Dana-Farber. It covers all fields and applications of the multiplexed technology, which makes possible the simultaneous detection of multiple DNA mutations from a single liquid sample, such as blood or urine.

Paul Kinnon, President and Chief Executive Officer of Transgenomic commented, "We believe MX ICE COLD-PCR is a critical enabling technology that represents a major leap forward in individualized cancer therapy. For the first time, it will allow comprehensive and affordable tumor genomic profiling without the need for tumor biopsies, a prerequisite if ongoing monitoring and optimization of cancer therapy is to become an everyday reality."

Mr. Kinnon continued, "Multiplexing makes our ICE COLD-PCR technology far more efficient and allows us to assemble targeted panels of relevant mutations that can be simultaneously analyzed from a single sample. This should greatly increase its availability for routine use in cancer therapy, as well as for our biopharmaceutical customers who plan to use MX ICE COLD-PCR to develop new cancer treatments and companion diagnostics."

ICE COLD-PCR selectively focuses on only the mutated DNA in tumors that is useful for cancer diagnosis, monitoring and treatment. It detects mutated DNA at very high sensitivity—initial validation studies show it is 100-400 fold more sensitive than conventional approaches. Uniquely, ICE COLD-PCR also enables identification of all tumor mutations - both those already known to cancer researchers as well as new mutations not detected before.

Importantly, the ultra-high sensitivity of ICE COLD-PCR allows DNA testing to be done using easily accessible samples, such as blood, plasma and urine, eliminating the need for tumor biopsies, which are invasive, painful and expensive. By enabling the use of these "liquid biopsies", ICE COLD-PCR makes it possible to conduct repeated assessments of a cancer patient's disease status both initially and as treatment proceeds, providing valuable information to help guide treatment decisions.

ICE COLD-PCR can also analyze DNA from fine needle aspirates, core-biopsies, or directly from tumors, and it can be used with standard Sanger sequencing, next generation sequencing, digital PCR and other technologies, as research in Dr. Mike Makrigiorgos' lab at Dana-Farber Cancer Institute has shown.

Transgenomic's current version of the ICE COLD-PCR technology is also exclusively licensed from Dana-Farber.

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