News | May 11, 2000

Third Wave Technologies' Invader Assay Scores High on Mutation Detection

Source: Third Wave Technologies Inc.
Third Wave Technologies Inc. (Madison WI) reports results from a multi-center study of its Invader operating system for DNA analysis in the May 2000 issue of the Journal of Molecular Diagnostics. The study, conducted by DNA diagnostic laboratories at the University of New Mexico, the University of Miami, and the Blood Center of Southeastern Wisconsin, found the Invader technology to be 99.5% accurate in detecting the factor V (Leiden) mutation directly from genomic DNA. (For a description of the Invader assay, click here.)

"The Invader technology is proving to be a powerful tool in the clinical lab," stated Richard Larson, director of the University of New Mexico Rapid Response Laboratory and lead author of the study. "The Invader technology offers faster throughput, reduced labor costs and is easily scaleable as the number of diagnostically important mutations and polymorphisms increases. The homogenous microtiter plate-based format also makes the assay adaptable for small or high-throughput labs, and the ease of integrating Invader technology smoothly into routine clinical workflow makes it an attractive alternative to current methods."

Researchers demonstrated that the Invader technology is highly effective in detecting the factor V (Leiden) mutation, the most common genetic risk factor in patients with deep vein thrombosis. In the published study, a total of 372 samples were analyzed to compare the Invader assay results with those from PCR-RFLP and/or Allele Specific (AS)-PCR analysis. The results of the Invader technology were found to be 99.5% concordant with these methods. While there are many other standardized assay formats with reliable performance, the study authors noted that other techniques are labor intensive and require expertise as well as specialized facilities and procedures to prevent contamination. This sharply limits their general applicability in diagnostic laboratories, particularly for higher volume applications.

"Invader technology overcomes the disadvantages of the current DNA diagnostic methods by offering a rapid, simple, and less expensive way for clinical laboratories to accurately detect important polymorphisms and mutations such as factor V (Leiden)," commented Lance Fors, president and CEO of Third Wave. "We believe that the Invader operating system will play a key role in the advent of personalized medicine."

Invader technology can be applied to the diagnosis of a wide spectrum of genetic-based diseases, to detect specific single nucleotide polymorphisms (SNPs), to quantitate gene expression and viral loads, and to test for drug resistance or mutations, providing a flexible platform technology with a wide breadth of applications for the clinical setting. Third Wave has agreements with major pharmaceutical companies and research institutes to use Invader technology for large-scale pharmacogenomics studies and emerging therapeutic selection applications.

Third Wave, a privately held company, entered into a definitive merger agreement with PE Biosystems, announced on January 24, 2000, pursuant to which PE Biosystems will acquire Third Wave, subject to customary closing conditions and regulatory approvals. Third Wave develops and provides DNA and RNA analysis technologies for use in genome research, pharmacogenomics, and clinical applications.

For more information: Lance Fors, Chief Executive Officer, Third Wave Technologies Inc., 502 South Rosa Rd., Madison, WI 53719. Tel: 800-856-4953.