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WIKI ANALYSIS
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.
On October 27, 2005 TWTI entered a preferred marketing relationship with Genzyme Genetics to provide testing with the Invader UGT1A1 Molecular Assay for colorectal cancer patients in the North American market who are being considered for, or currently taking, the chemotherapy Camptosar (irinotecan).
On March 2, 2006, TWTI signed an agreement with Shimadzu Corp. and Toppan Printing Co for the development and commercialization of a point-of-care instrument targeting molecular diagnostics for use in primary care. The device is expected to be the world's first fully-automated system for nucleic acid analysis capable of analyzing a patient's DNA for specific gene sequences from a drop of whole blood in approximately 90 minutes. Shimadzu and Toppan developed the instrument in partnership with Dr. Yusuke Nakamura of the RIKEN Institute/University of Tokyo. Under the agreement the companies will apply Third Wave's Invader chemistry to the instrument for detection of variations in cytochrome P450 genes that can cause adverse drug reactions.
On April 5, 2006 TWTI formed a joint venture with Mitsubishi to accelerate the development and commercialization of clinical molecular diagnostic products and pharmacogenetics in Japan and throughout the Asia-Pacific region. The joint venture is being formed through Mitsubishi's minority investment in Third Wave Japan. Upon closing of the investment, Mitsubishi will own approximately 14% of Third Wave Japan. CSK Holdings Corporation, through its new subsidiary CSK Institute for Sustainability, Ltd. and will own approximately 3% of Third Wave Japan. Furthermore TWTI will have worldwide rights outside the Asia-Pacific region to any new technology or product developed by Third Wave Japan.
On August 7, 2006, TWTI announced that the clinical trial for its two human papillomavirus, or HPV, products had commenced, with submission of applications for approval of these products to the U.S. Food and Drug Administration (FDA) expected in 2007.
On January 29, 2007, TWTI and Stratagene entered into an out-of-court settlement regarding litigation over an alleged patent infringement concerning the proprietary Invader chemistry. Under the terms of the settlement Stratagene paid the company $10.75M in cash to satisfy the outstanding judgment and dropped its appeal in its entirety. The parties also agreed to dismiss all litigation, including the suit filed by Stratagene against Third Wave in the District of Delaware.
In January 2007, Digene Corporation (which has since been acquired by Qiagen) initiated legal proceedings related to alleged patent infringements, against TWTI over the company's Human Papillomavirus (HPV) products. TWTI responded by denying infringement and alleging anti-competitive business practices and anti-trust violations by Digene.
On July 17, 2007, TWTI announced its collaboration with Laboratory Corp. of America Holdings Inc. to develop diagnostic tests to help doctors personalize drug treatment for heart failure patients.
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