OMAHA, Neb.--(BUSINESS WIRE)-- Transgenomic, Inc. (OTCBB:TBIO.OB - News) today announced it has achieved CE IVD Mark registration in Europe for the diagnostic use of its proprietary WAVE MCE System and SURVEYOR® Scan KRAS Kit. Analysis of the KRAS gene is critical for treatment decision-making in many cancer types. Gaining the CE IVD Mark enables diagnostic product sales in countries in the European Union.
The SURVEYOR® Scan KRAS Kit includes a simple, highly sensitive, accurate, proprietary test used to identify mutations in the KRAS gene, an important marker exhibited by drug resistant tumors. Mutations in the KRAS gene are key determinants of the effectiveness of modern cancer drugs such as Erbitux® (cetuximab) and Vectibix®(panitumumab), and detection of this mutation is important for the physicians’ decision-making regarding the best course of treatment for their patients. The SURVEYOR® Scan KRAS Kit uses the established SURVEYOR® Nuclease technology and is used exclusively with Transgenomic’s proprietary WAVE® Microchip Electrophoresis (MCE) System. The SURVEYOR® Scan KRAS Kit will be distributed in Europe through the Company’s agreement with A. Menarini Diagnostics S.r.l.
“Achieving the CE IVD Mark is an important milestone for maximizing the commercial potential of our WAVE MCE System and the SURVEYOR®Scan KRAS Kit; it enhances our products and technology offerings in Europe, which are sold through our partnership with A. Menarini Diagnostics,” said Craig Tuttle, Chief Executive Officer of Transgenomic. “Our technologies, including the KRAS detection kit, are specially designed to provide the highest level of sensitivity and specificity, and to find low level mutations frequently missed by typical gene sequencing.”
The CE IVD Mark is a requirement for in vitro diagnostic medical devices placed on the market in Europe. The CE IVD Mark allows the SURVEYOR® Scan KRAS Kit to be sold and used as a diagnostic kit in the United Kingdom (UK), Germany, and France, along with many other European countries. In addition, the CE IVD Mark is an important benchmark for product adoption in territories outside the EU. Transgenomic believes this CE IVD Mark will assist them in their continuing efforts to expand the use of the SURVEYOR® Scan products in emerging markets. A. Menarini Diagnostics S.r.l. expects to distribute the SURVEYOR® Scan KRAS Kit in the UK, Ireland, Austria, Belgium, France, Germany, Greece, Italy, The Netherlands, Portugal and Spain.
About the SURVEYOR®Scan Mutation Detection Kits and SURVEYOR®Nuclease Technology
SURVEYOR® Scan Mutation Detection Kits provide reagents and protocols for the detection of DNA mutations. All of these kits are based on the use of SURVEYOR® Nuclease, a mismatch-specific endonuclease derived from celery that has been shown to recognize and cleave all types of mismatches arising from the presence of point mutations, insertions, deletions and single nucleotide polymorphisms (SNPs). SURVEYOR® Nuclease-based applications provide a powerful method to detect somatic mutations in gene pathways that are becoming increasingly important in research efforts to understand and treat various cancers. For several years, SURVEYOR® Nuclease technology has been recognized as having superior detection capability over standard sequencing methods and it is now available in user-friendly mutation detection kits for a variety of genes. In addition to detecting the most common activating mutations, it will detect other mutations that current sequence-specific methods do not find. The SURVEYOR® Scan Mutation Detection Kit for the WAVE MCE System is currently available for the KRAS gene with future kits for EGFR, BRAF and PIK3CA.
About the WAVE®Microchip Electrophoresis (MCE) System
Transgenomic’s WAVE® MCE System is based on size fractionation of DNA using microchip electrophoresis. This system offers discovery and detection of genetic variation at close to 100% sensitivity for both known and unknown mutations and single nucleotide polymorphisms (SNPs). The long-established WAVE® HS platform utilizes denaturing high-performance liquid chromatography (DHPLC); this range of systems is used throughout the world to screen for a large variety of diseases and more than 350 human genes have been screened entirely or partly by DHPLC. The WAVE® MCE, the newest member of Transgenomic’s WAVE platform family, brings the power of SURVEYOR® Nuclease applications to the simplicity of microchip electrophoresis.
About Transgenomic, Inc.
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, which specializes in molecular diagnostics for cardiology, neurology, mitochondrial disorders, and oncology, and Transgenomic Diagnostic Tools which 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.
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Transgenomic, Inc.
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