Transgenomic, Inc. (OTCBB: TBIO) today announced the global, commercial availability of CRC RAScan™, a new mutation detection test to screen patients with metastatic colorectal cancer (mCRC) for RAS mutations (KRAS and NRAS). These RAS mutations, identified using the CRC RAScan™ kits which use Surveyor®-Wave® technology, provide physicians with important information regarding tumor mutation status to help with clinical treatment decisions for their mCRC patients. Transgenomic’s CLIA-certified laboratory in the United States (U.S.) is available immediately to receive patient samples for testing. In Europe, CE-IVD registered test kits are available for purchase. Research-only test kits will soon be available for purchase in the U.S.
The CRC RAScan™ kit was developed in collaboration with Amgen Inc. (NASDAQ: AMGN), and follows discovery of RAS (KRAS and NRAS) mutations in a predefined-retrospective subset analysis of a global, multicenter, randomized Phase 3 study. Results of this analysis will be presented at the 2013 ASCO Annual Meeting on June 4 (Abstract Number 3511; 8:00 a.m. - 12:00 p.m. CDT, S405).
“Our partnership with Amgen, and development of CRC RAScan, supports our goal of developing predictive tests that can help physicians make decisions when selecting treatment options for patients,” said Craig Tuttle, Chief Executive Officer of Transgenomic. “CRC RAScan is the only dedicated test available today that identifies the full range of RAS mutations to help with treatment decisions for patients with metastatic colorectal cancer.”
For more information about how to order a CRC RAScan test or to obtain a mutation detection test kit, contact Transgenomic at 888-813-7253 or 402-452-5400 or by email at ClientServices@Transgenomic.com. You can also visit the Company’s website at http://www.transgenomic.com/mcrc-support.
About CRC RAScan
CRC RAScan utilizes the DNA mismatch-cutting enzyme SURVEYOR Nuclease, developed exclusively by Transgenomic. This enzyme recognizes nucleotide mismatches in a mixture of wild-type and mutant DNAs reflective of what is found in tumor biopsy samples. The enzyme cleaves at the site of the mismatch; cleavage products can be very simply detected and are indicative of the presence of a potential mutation in a target DNA sequence. Sanger sequencing can subsequently identify the detected base change in gene regions covered by the CRC RAScan test. The SURVEYOR Nuclease assay, which is more sensitive for mutation detection than stand-alone Sanger sequencing, can be used to help resolve marginal and low level sequencing results. Therefore, the CRC RAScan test provides increased sensitivity for the detection of mutations at relevant levels for optimal therapy selection. Additionally, in gene regions where mutations exist at low frequencies, prescreening with CRC RAScan affords a cost and time-efficient workflow, as only CRC RAScan positive samples are advanced to the more complex and expensive Sanger sequencing analysis.
About Colorectal Cancer
Colorectal cancer is the fourth most common cancer diagnosed in men and in women in the United States. The American Cancer Society estimated that about 102,480 new cases of colon cancer and 40,340 new cases of rectal cancer will be diagnosed in 2013. Colorectal cancer is the second most frequent cause of cancer death among men and women in the United States. It has been estimated that 50,830 people will die from colorectal cancer in 2013.
More About RAS Mutations
KRAS and NRAS are part of the RAS family of genes that encodes proteins involved in transmitting signals within cells. When RAS proteins are “switched on” by incoming signals, other genes involved in cell growth, differentiation and survival are activated. Mutations in KRAS, NRAS and other related genes can lead to RAS-encoded proteins becoming permanently activated, causing overactive signaling even in the absence of incoming signals, and can lead to the uncontrolled cell growth that characterizes cancer. Mutations that permanently activate RAS-encoded proteins are found in approximately 25% of human tumors and up to 90% of certain cancers. About 40% of colorectal tumors carry KRAS gene mutations and these mutations have been associated with poor response to EGFR antagonists.
About Transgenomic, Inc.
Transgenomic, Inc. (www.transgenomic.com) is a global biotechnology company advancing personalized medicine in cardiology, oncology, and inherited diseases through its proprietary molecular technologies and world-class clinical and research services. The Company is a global leader in cardiac genetic testing with a family of innovative products, including its C-GAAP test, designed to detect gene mutations which indicate cardiac disorders, or which can lead to serious adverse events. Transgenomic has three complementary business divisions: Transgenomic Clinical Laboratories, which specializes in molecular diagnostics for cardiology, oncology, neurology and mitochondrial disorders; Transgenomic Pharmacogenomic Services, a contract research laboratory that specializes in supporting all phases of pre-clinical and clinical trials for oncology drugs in development; 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 strengthens its leadership in personalized medicine.
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.
David Pitts, 212-600-1902
Investor Relations, 402-452-5416
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