High sensitivity research-use kit for broad detection of mutations predictive of response to recently developed therapies

OMAHA, Neb. — Transgenomic, Inc. (OTC BB: TBIO.OB) announced today the launch of its SURVEYOR Scan K-RAS kit, the first in a family of mutation detection kits the company plans to offer featuring its proprietary SURVEYOR Nuclease and WAVE® HS DHPLC platform. SURVEYOR Scan technology is a novel approach to mutation detection that uses a PCR amplification reaction and hybridization to form heteroduplex DNA molecules in samples with K-RAS mutation. A digestion step is performed using SURVEYOR Nuclease, which cuts the DNA strands at mismatched base pairs. The different sized pieces of DNA are recognized as additional peaks on a chromatogram when compared to non-mutant DNA. K-RAS mutations are associated with lack of response to therapies directed against the epidermal growth factor receptor (EGFR) in colorectal cancer.

“For several years SURVEYOR technology has been recognized as having superior detection capability over standard sequencing, and so we have developed it into a user-friendly kit for K-RAS,” said Transgenomic’s Chief Scientific Officer, Dr. Eric Kaldjian. “In addition to detecting the most common activating mutations, it also detects other mutations that current sequence-specific methods will not find. This technology will have very practical extensions to tumor suppressor genes, such as p53, in which mutations of clinical significance may be present throughout a gene.”

In a lung cancer study presented by OSI Pharmaceuticals, Inc. at the annual meeting of the 2009 American Association for Cancer Research, SURVEYOR Scan K-RAS was compared with standard sequencing and Scorpions ARMS, an allele-specific test. The study demonstrated that the SURVEYOR method was more sensitive then sequencing and a better predictor of response to single-agent anti-EGFR therapy than Scorpions ARMS.

“We are very pleased to announce the launch of our SURVEYOR Scan K-RAS kit,” said Craig Tuttle, Transgenomic’s Chief Executive Officer. “We have long believed that SURVEYOR Nuclease based applications will be a powerful method to detect somatic mutations in gene pathways that are becoming increasingly important in selecting appropriate treatments for cancer patients. By combining SURVEYOR Nuclease with the WAVE HS platform we have created an accurate, easy to use, simple to interpret and cost effective way to find somatic mutations in genes such as K-RAS. SURVEYOR Scan K-RAS will be the first of several mutation detection kits we are developing for diagnostic use with WAVE HS. Additionally, we will be able to develop SURVEYOR Scan kits on other instrument platforms; we believe that this will enhance the adoption of our assay.”

About the SURVEYOR Scan K-RAS Mutation Detection kit for WAVE HS Systems

Numerous scientific studies report that K-RAS mutation status is a strong predictor of resistance to cancer treatment with epidermal growth factor receptor inhibitors. Transgenomic’s SURVEYOR Scan K-RAS Mutation Detection Kit uses the established SURVEYOR Nuclease technology employed in the OSI study to identify mutations in the K-RAS gene that are associated with drug-resistant tumors.

Key features include:

– Detects mutations by enzymatic cleavage at mutation sites

– Identifies all known and unknown mutations in both K-RAS coding exons

– Includes control templates for common mutation sites (codons 12, 13 and 61)

– High analytic sensitivity — detects 1% of K-RAS mutant in a background of wild-type genomic DNA

– Finds low level mutations frequently missed by sequencing

– Simple interpretation — the SURVEYOR fragment analysis pattern can identify the position of the mutation without additional sequencing cost

– Can be applied to formalin-fixed paraffin-embedded tissues

SURVEYOR Scan K-RAS is the first of a series of kits for use in cancer mutation detection. Transgenomic plans to follow it with kits for BRAF, p53 and other important cancer pathway gene mutations kits in the near future.

About Transgenomic, Inc.

Transgenomic, Inc. (OTC BB: TBIO.OB, www.transgenomic.com) is a global biotechnology company specializing in high sensitivity genetic variation and mutation analysis, providing products and services in DNA mutation detection and discovery for clinical research, clinical molecular diagnostics and pharmacogenomics analyses. Its product offerings include the WAVE® Systems and associated consumables specifically designed for use in genetic variation detection and single- and double-strand DNA/RNA analysis and purification. With broad applicability to genetic research, over 1,450 systems have been shipped to customers in more than 30 countries. The SURVEYOR® Mutation Detection Kits and SURVEYOR Check-It Kit provide reagents and protocols for high sensitivity detection of mutations in DNA. In addition, HANABI automated chromosome harvesting systems improve laboratory productivity with consistent quality compared to manual methods for cytogenetic analyses. Service offerings include the Transgenomic Molecular Laboratory, which provides reference laboratory services specializing in molecular diagnostics including Mitochondrial Disorders, Oncology and Hematology, Molecular Pathology and Inherited Diseases. Transgenomic Pharmacogenomic Services is a CRO for pharmacogenomic, translational research and clinical trials.

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