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.
"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."
About the SURVEYOR® Nuclease and WAVE® MCE platform
SURVEYOR Scan technology is a novel approach to mutation detection that uses a PCR amplification reaction and hybridization to form mis-paired DNA molecules where there are mutations. A digestion step is performed using SURVEYOR Nuclease that cuts the DNA strands at these mismatched base pairs. The different sized pieces of DNA are recognized as additional peaks on a chromatogram when compared to non-mutant DNA controls. Key features of the SURVEYOR Scan Kits include:
- High analytic sensitivity "” detects 1"´2% of a mutant population in a background of wild-type genomic DNA
- Identification of all known and unknown mutations in the amplicon of interest
- Detection of low level mutations frequently missed by sequencing
- Successful application to DNA extracted from formalin-fixed paraffin-embedded tissues
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 A. Menarini Diagnostics
A. Menarini Diagnostics is committed to becoming the world leader in well defined and selected diagnostic areas by providing exclusive, reliable, and scientifically advanced solutions, capable of exceeding customer expectations. The Company has dedicated more than 30 years to its continuous expansion and growth, going above and beyond any immediate geographical barriers, opening up new frontiers in the world of diagnostics so that the new challenges offered by today´s market may be turned into opportunities which can be rewardingly overcome. A. Menarini Diagnostics has always put their collective knowledge and know-how at the service of both healthcare professionals and patients alike, guaranteeing that people all around the globe may reap the benefits of their longstanding efforts and deep-rooted experience.
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 management´s current views and estimates of future economic circumstances, industry conditions, company performance and financial results, including the ability of the Company to grow its involvement in the diagnostic products and services markets. 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.