Transgenomic Announces Discovery of a Novel Technique Which Enhances Analytic Sensitivity of Standard Sanger Sequencing to 1%

OMAHA, Neb., March 29, 2011 /PRNewswire/ -- Transgenomic, Inc. (OTC Bulletin Board: TBIO) today announced that it has discovered a novel sequencing technology, which the company has termed BLOCker-Sequencing (BLocking Oligonucleotides in Cycle sequencing), which enhances the limit of detection of standard Sanger Sequencing, enriches for direct sequencing of mutated DNA over wild-type (unmutated DNA) and can be run on standard Sanger Sequencing equipment.  

BLOCker-Sequencing is an approach which selectively blocks the sequencing of wild-type DNA and allows samples with lower concentrations of mutant DNA to be sequenced for any mutation using standard Sanger Sequencing techniques.  BLOCker-Sequencing can be easily used with any PCR amplified nucleic acid fragment with minimal modifications to the standard cycle sequencing protocols.

BLOCker-Sequencing incorporates two additional steps prior to annealing of the sequencing primer in the standard Sanger sequencing protocol, a hybridization of a blocking oligonucleotide which is complementary to the wild-type DNA sequence and then a denaturing step at a critical temperature at which the BLOCker-oligo remains annealed to the wild-type sequence but not the mutant sequence.  The sequencing primer will then preferentially anneal and sequence the mutant but not the wild-type DNA.  

Dr. Katherine Richardson, Transgenomic's Vice President of Research and Development, said, "Standard Sanger Sequencing is considered by many to be the gold standard in mutation detection and identification.  However, it has limitations in finding low level DNA mutations such as those found in many cancers.   If you have a tumor with a mutant to wild-type ratio of 1:10 or lower, you will most likely not detect the mutation using standard sequencing techniques.  By adding BLOCker-Sequencing to the Sanger Sequencing protocol, we have shown we can identify mutations in samples with a mutant to wild-type ratio of 1:100.  We have also shown that BLOCker-Sequencing can discriminate different viral strains which co-elute using DHPLC.  The studies we have performed to date prove that BLOCker-Sequencing is a pivotal methodology for enhancing the mutation detection capabilities of Sanger Sequencing to levels equal to or better than commercially available allele-specific, pyrosequencing and next generation sequencing methods."

Craig Tuttle, Chief Executive Officer and President of Transgenomic commented, "BLOCker-Sequencing is a very exciting discovery.   Our studies have shown that BLOCker-Sequencing will provide a key enhancement to standard Sanger Sequencing.  It extends the utility of using Sanger Sequencing to easily and sensitively measure somatic mutations in cancer similar to how it is used in other areas of diagnostic medicine to measure germ line mutations.  In addition, BLOCker-Sequencing can be combined with our COLD-PCR technologies to provide ultra-sensitive DNA mutation detection allowing us to look for DNA mutations in a patient's blood sample rather than requiring a tumor sample.  Offering a BLOCker-Sequencing and COLD-PCR kit will extend the ability of labs to employ our combined technology for ultra-sensitive mutation detection using equipment and techniques they already have and are widely accepted by regulatory agencies worldwide as the gold standard for mutation detection.  We believe BLOCker-Sequencing coupled with COLD-PCR could revolutionize mutation detection assay technology."

A provisional patent for this new discovery has been filed in the United States.

About Transgenomic, Inc.

Transgenomic, Inc. (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. 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, nearly 1,500 systems have been shipped to customers in more than 50 countries. The SURVEYOR® Mutation Detection Kits provide reagents and protocols for high sensitivity detection of mutations in DNA.  HANABI automated chromosome harvesting systems improve laboratory productivity with consistent quality compared with manual methods for cytogenetic karyotyping and FISH 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 Pharmacogenomics Services is a CRO for pharmacogenomic, translational research and clinical trials. In December of 2010, we acquired another CLIA certified laboratory in New Haven, Connecticut which specializes in genetic disorders associated with cardiomyopathies and channelopathies. We believe there is a significant opportunity for us to continue growing the demand for molecular-based testing by leveraging our technologies, experience and expertise in biomarker analysis. In addition, we continue to seek out and evaluate new technologies and new laboratory tests which will further extend our offerings in our Molecular Diagnostics Laboratory and our Pharmacogenomics Services Lab.

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.

SOURCE Transgenomic, Inc.