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Third Wave Technologies, Inc. (TWTI), based in Wisconsin, was founded in 1993 and went public in 2001, targeting the life science market with its novel technology platform for the analysis of genetic data. In 1994, the company launched its first proprietary "Invader" assay system, using the patented Cleavase enzymes and CFLP (cleavase fragment length polymorphism) assay targeting the life science research community. The Invader system allowed researchers to target any predetermined sequence of nucleic acids at a lower cost, using smaller samples and fewer process steps than conventional sequencing approaches. The company's proprietary chemistry platform is based on a unique class of structure-specific endonucleases, or Cleavase enzymes, originally studied at the University of Wisconsin-Madison (UW). The technology is patented by the Wisconsin Alumni Research Foundation, which manages the patents and licensing for UW. These enzymes were able to recognize DNA secondary structures that form as DNA coils following brief thermal denaturation, providing scientists with a method of identifying predetermined sequences of nucleic acids, and, in particular, single nucleotide polymorphisms (SNPs). SNPs are single-based variations scattered throughout the human genome and believed to be responsible for most genetic variations.
Approximately 35% of revenues are currently derived from molecular diagnostic sales. Approximately 160 clinical laboratory customers are using Third Wave's molecular diagnostic reagents. Other customers include pharmaceutical and biotechnology companies, academic research centers and major health care providers. In the clinical molecular diagnostic arena, the company is a relative newcomer, and currently targets five major market segments: 1.) Genetic testing, related to multiple disease areas, 2.) Pharmacogenetics, 3.) Chromosomal analysis, 4.) Infectious diseases, and 5.) Human Papilloma Virus (HPV) in women's health. The market for molecular diagnostics is dynamic with significant competition from large, well-entrenched players, such as Roche Diagnostics, Gen-Probe, Celera Diagnostics, and Abbott Laboratories. Nonetheless, the largest volume of patient samples is concentrated among a small number of large commercial laboratories, which confers strategic advantages to even smaller players with a technologically competitive product offering.