Transgenomic and A. Menarini Diagnostics enter distribution agreement for mutation detection systems

Transgenomic, Inc. (OTC/BB: TBIO) and A. Menarini Diagnostics today announced an exclusive distribution agreement for Transgenomic's SURVEYOR^® Scan and WAVE^® MCE (Micro-Capillary Electrophoresis) Mutation Detection system to its network of over 2,000 pathologists throughout Europe.

“A comparison of KRAS Mutation Detection Methods Using Samples from a Phase 2 Study in NSCLC”

"This agreement opens up a broad new channel for SURVEYOR Scan and WAVE MCE targeted to pathologists throughout Europe," said Craig Tuttle, Transgenomic's Chief Executive Officer. "Over the last two years, Transgenomic has been marketing SURVEYOR based mutation detection kits for key cancer genes like KRAS, BRAF and PI-3 Kinase for our WAVE systems. Earlier this year, we began development of these kits for the WAVE MCE, a faster, lower cost system which has exhibited equivalent analytic sensitivity to the WAVE and better analytic sensitivity than competitive technologies typically used for this testing. We are excited about our relationship with A. Menarini Diagnostics as it will accelerate the adoption of our SURVEYOR Scan Mutation Detection kits and WAVE MCE platform among this key market segment."

Transgenomic's SURVEYOR Scan and WAVE MCE Mutation Detection system offers a simple to use, easy to interpret and cost effective approach to mutation detection testing. Transgenomic's SURVEYOR Scan KRAS kit has been shown to have equivalent performance when compared with allele specific methods such as Scorpion ARMS and Pyrosequencing. In an abstract presented at the 2009 AACR meeting titled "A comparison of KRAS Mutation Detection Methods Using Samples from a Phase 2 Study in NSCLC", SURVEYOR Scan KRAS was compared with allele specific PCR. The study reported that SURVEYOR Scan had sensitivity of 100% and specificity of 94% versus sensitivity of 81% and specificity of 65% for Scorpion ARMS allele specific PCR. In a second study done on colorectal cancer by the Laboratory for Molecular Biology and Tumor Cytogenetics at the Krankenhaus der Barmherzigen Schwestern (Hospital of the Sisters of Mercy), in Linz, Austria, 100 samples were tested. SURVEYOR Scan was found to have sensitivity of 98% and specificity of 100%.

"A. Menarini Diagnostics strives to bring the best new technologies to our pathology customers," said Dr. Crescenzio Izzo, General Manager of A. Menarini Diagnostics. "SURVEYOR Scan and the WAVE MCE platform bring a simple but powerful solution to Pathologists looking to offer a molecular pathology service. We look forward to working with Transgenomic to provide these technologies and their coming ICE COLD-PCR technology to the pathology community throughout Europe."