Third Wave: Receives FDA Clearance of Pharmacogenetic Test


Third Wave Technologies

Rod Hise

(608) 663-4010

Vida Communication
Stephanie Diaz (investors)
(415) 885-2298

Tim Brons (media)
(646) 319-8981

For Immediate Release

MADISON, Wis., Aug. 22, 2005—Third Wave Technologies Inc. (Nasdaq: TWTI) today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Invader® UGT1A1 Molecular Assay for in vitro diagnostic use. It is the first pharmacogenetic test to be approved by the FDA for use as a companion diagnostic to a specific drug therapy.

The Invader® UGT1A1 test is cleared for use to identify patients who may be at increased risk of adverse reaction to the chemotherapy drug Camptosar (irinotecan) by detecting and identifying specific mutations in the UGT1A1 gene that have been associated with that risk. Camptosar is used to treat colorectal cancer and was relabeled recently to include dosing recommendations based on a patient’s genetic profile.

“The selection of the right dose is one of the greatest challenges in the treatment of cancer patients,” said Dr. Howard L. McLeod, professor of oncology at Washington University School of Medicine and a recognized thought-leader in the field of pharmacogenetics. “The recent expansion of available therapies for colorectal cancer has made toxicity avoidance an important aspect of the clinical decision.”

The FDA, in its own news release announcing the approval of the Third Wave test, said its use could provide colorectal cancer patients with significant medical benefit. Approximately 150,000 new cases of colorectal cancer are diagnosed each year in the United States.

Third Wave’s UGT1A1 molecular diagnostic test is built on the accuracy, scalability and ease of use of the company’s unique, patented Invader® chemistry. In a study submitted to the FDA as part of the company’s clearance application, the Invader® UGT1A1 Molecular Assay was 100% accurate1 compared to DNA sequencing, the standard for genotype determination.

“Third Wave has positioned itself for leadership in the emerging pharmacogenetic market with the FDA’s approval of our UGT1A1 molecular diagnostic test,” said John J. Puisis, president and chief executive officer of Third Wave. “We were very pleased to work with the FDA at its request on this cutting-edge, companion diagnostic.

“While the pharmacogenetic market is just beginning to emerge, we believe it will become increasingly valuable,” Mr. Puisis said. “Our goal is to ensure that Third Wave is well positioned to capture that value as the market develops and molecular diagnostic and drug pairings continue to be identified, as we expect they will be.”

1n=285; 95% lower limit confidence=99%

About Third Wave Technologies

Third Wave Technologies is a leader in the development and marketing of molecular diagnostics for a variety of DNA and RNA analysis applications, providing physicians and researchers with superior tools to diagnose and treat disease. Third Wave’s Invader® chemistry provides the company’s customers with exceptional performance, scalability, and ease of use. The company offers a number of clinical products based on its Invader® chemistry for genetic testing related to multiple disease areas. For more information about Third Wave and its products, please visit the company’s website at

All statements in this news release that are not historical are forward-looking statements within the meaning of the Securities Exchange Act of 1934 as amended. Such forward-looking statements are subject to factors that could cause actual results to differ materially for Third Wave from those projected. Those factors include risks and uncertainties relating to the company’s ability to bring new products to market as anticipated, the current regulatory environment in which the company sells its products, the market acceptance of those products, dependence on partners and customers, successful performance under collaborative and commercial agreements, competition, the strength of the Third Wave intellectual property, the intellectual property of others and other risk factors identified in the documents Third Wave has filed, or will file, with the Securities and Exchange Commission. Copies of the Third Wave filings with the SEC may be obtained from the SEC Internet site at Third Wave expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Third Wave’s expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based. Third Wave Technologies, Invader and the Third Wave logo are trademarks of Third Wave Technologies Inc.