Third Wave Technologies, a closely-held emerging genomics company, announced today that researchers from the University of Wisconsin have confirmed findings that the Company's technology for analyzing DNA samples directly without standard amplification processes is highly accurate, cost-effective and efficacious when compared to other genotyping and analysis methods. University researchers, who published their results in the Proceedings of the National Academy of Sciences in May (Vol. 96, pp. 6301-6306), also found that Third Wave's Invader assays were transferable to other advanced gene discovery platforms.

Third Wave's Invader(TM) technology is being implemented in the identification of single nucleotide polymorphisms (SNPs), and other genetic variations, associated with specific diseases from large population studies. The Company has contracts with leading genome-sequencing companies, as well as collaborations with the Sanger Centre, Cambridge University and the Stanford Genome Center.

"The Invader assay is an extremely powerful approach to high-throughput genotyping of SNPs for genetic analysis,'' said Lloyd M. Smith, Ph.D., senior author of the study and Kellett Professor at the University of Wisconsin, who is also one of Third Wave's founders and directors. "Third Wave's assays are easy to design, more robust than DNA sequencing and don't suffer the carryover contamination issues often associated with other methods. We also found it has a high level of transferability, allowing us to take the core technology and make it even more powerful using advanced methods under development.''

The purpose of the study was to examine the use of Invader technology in the analysis of SNPs directly from genomic DNA, and to determine if the assays were easily transferable to alternative platforms. Unlike almost all existing methods for SNP analysis, Invader technology does not require the use of Polymerase Chain Reaction (PCR), a complex method that generates millions of copies of a particular gene sequence to enrich that sequence for subsequent analysis. PCR inherently has significant shortcomings, some of which are carryover contamination, allele specific amplification and yield inconsistency in addition to variability of optimal reaction conditions.

"Given these inherent limitations to PCR-based high-throughput SNP analysis methods, it is clear that the development of simpler and more direct analysis approaches would be desirable,'' the journal paper stated. "Our results show that this (Invader) approach is simple, robust and accurate.''

Specifically, the study involved the analysis of 12 SNPs genotyped directly from genomic DNA by using the Invader method. The researchers applied the assays to a technology known as mass spectrometry, one of the most advanced methods available to identify specific molecules in a fraction of a second, as opposed to hours or days with other techniques. Results from the Invader assay and a mass spectrometry analysis of the SNPs performed on the university's MALDI-TOF mass spectrometry system were unambiguous and reproducible, the study found.

"Every assay we developed based on the Invader technology worked the first time around. That's unusual in molecular biology,'' Dr. Smith said. "Everything looks good on paper. This actually worked in the lab.''

Assays incorporating the Invader technology are being formatted to operate with equipment found in most research and clinical labs, greatly enhancing its commercial potential. The technology relies on Third Wave's proprietary Cleavase (R) family of enzymes that recognize specific DNA and RNA structures.

"Invader technology is highly accurate and cost-effective due to its inherent specificity and efficiency, and is poised to become a standard in the industry,'' said Lance Fors, CEO of Third Wave Technologies. "This study also proves that it also has wide applicability to the most advanced molecular detection platforms.''

The study described in the journal article was not funded by the Company.

Third Wave Technologies is a genomics company commercializing applications for the rapid and efficient analysis of DNA and RNA. The Company's proprietary technology is being developed for use in the pharmaceutical, agricultural, molecular research and clinical diagnostic industries.

Company news release
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