Transgenomic and ScreenCell Announce Worldwide Distribution and Collaboration Agreement for Circulating Tumor Cell (CTC) Technology

OMAHA, Neb. & PARIS–Transgenomic, Inc. and ScreenCell, a privately-held company, today announced the signing of a perpetual, worldwide collaboration and distribution agreement for ScreenCell’s Isolation Devices and Dilution Buffers, designed for the collection of Circulating Tumor Cells (CTCs) in peripheral blood. ScreenCell® offers innovative, single-use devices to isolate by size and characterize all possible tumor cells, including mesenchymal cells. Mesenchymal cells, thought to be cancer stem cells important in cancer assessment, are not collected through technologies that only target cells expressing EpCam, a transmembrane glycoprotein on epithelial cells. Their collection is therefore a key advantage of ScreenCell’s technologies. Collected cells are also well preserved morphologically, allowing isolation of live cells able to grow in culture and collection of high quality genetic materials.

The agreement makes Transgenomic the exclusive distributor of ScreenCell technologies used in combination with Transgenomic’s industry leading high-sensitivity mutation detection products, including its ICE COLD-PCR assays, BLOCker-Sequencing cancer mutation assays, SURVEYOR Scan cancer mutation kits and WAVE instrument systems. The Company expects to begin selling ScreenCell products immediately, in combination with Transgenomic technology, as part of its pharmacogenomic services and for other, non-exclusive broad research applications to drug developers and academic centers.

“This agreement is an important marriage of technologies, one designed to isolate rare cells of potentially significant prognostic value in cancer, and another, our ICE-COLD PCR, designed to enrich mutations to levels that can be detected even in small CTC cell loads and amidst competing wild-type DNA,” stated Craig Tuttle, President and Chief Executive Officer of Transgenomic. “In the longer-term, we look forward to offering CTC collection as a combined kit product with our ICE-COLD PCR kits. Combined again with our ultra high-sensitivity genetic variation and mutation analysis capabilities, we believe this platform may have a dramatic impact on disease detection, treatment, management and outcome in cancer. We are proud to be ScreenCell’s first global partner and look forward to our validation work with these technologies.”

“Our goal in designing ScreenCell technologies was to create a universal system, not limited to detection of cells of nonepithelial origin and free of any bias potentially linked to the use of antibodies for cell capture,” stated David Znaty, Chief Executive Officer of ScreenCell. “Our goal is to support a breakthrough in personalized medicine by creating a non-invasive evaluation of specific therapeutic targets and ‘real time’ monitoring of target evolution under the pressure of targeted therapies in cancer. We are excited to work with Transgenomic not just for their commercial strength, but because we believe strongly in our combined technologies.”

Both companies have agreed to support the development of the combined technologies which, to date, have been tested in a proof of concept study at the Dana Farber Cancer Institute. Transgenomic and ScreenCell plan additional validation efforts with Dana Farber and other key researcher institutions to further establish the ability to isolate CTCs and, using the combined products, find new marker genes which may be involved in early diagnostic as well as mutations involved in determining, prognosis and therapeutic response. Transgenomic plans to begin the validation process for the combined products immediately, with the goal of commercializing such an offering for clinical trial use.

About Transgenomic

Transgenomic, Inc. (www.transgenomic.com) is a global biotechnology company advancing personalized medicine in cancer and inherited diseases through its proprietary molecular technologies and world-class clinical and research services. The Company has three complementary business divisions: Transgenomic Pharmacogenomic Services is a contract research laboratory that specializes in supporting all phases of pre-clinical and clinical trials for oncology drugs in development. Transgenomic Clinical Laboratories specializes in molecular diagnostics for cardiology, neurology, mitochondrial disorders, and oncology. Transgenomic Diagnostic Tools produces equipment, reagents, and other consumables that empower clinical and research applications in molecular testing and cytogenetics. Transgenomic believes there is significant opportunity for continued growth across all three businesses by leveraging their synergistic capabilities, technologies, and expertise. The Company actively develops and acquires new technology and other intellectual property that strengthen its leadership in personalized medicine.

About ScreenCell

ScreenCell was founded with the objective of designing and producing a simple but revolutionary technique allowing the fast and effective filtering of Rare Circulating Cells yielding high quality CTC population amenable to better cellular and molecular characterization.

ScreenCell designed a full range of point of care devices compatible with existing In vitro Diagnostics (IVD) assays and platforms, with no need for any interface development.

ScreenCell is dedicated to creating technologies allowing CTCs to become potential end points in future oncology therapeutic arsenals, by filtering out healthy live tumor cells, thus enabling:

. molecular biology

. cell culture

. enumeration and cytomorphology evaluation

The technology has also demonstrated its advantages for the isolation of Circulating Fetal Cells (CFCs) drawn from peripheral blood of pregnant women, potentially leading to a significantly facilitated and cost-effective process for prenatal diagnosis of genetic diseases.

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