Transgenomic Inc., a global biotechnology company, 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 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 US.

The CRC  RAScan kit was developed in collaboration with Amgen  Inc., 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.

“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.”

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 tumour 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.

Transgenomic, Inc. 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.