MADISON, Wis., Jan. 20 — Third Wave Technologies, Inc. (Nasdaq: TWTI), a leader in molecular diagnostics, today announced that it has achieved ISO 13485:2003 certification, a stringent, globally-recognized standard of quality management for medical device manufacturers. The designation was earned from BSI Management Systems, the world’s leading international standards, testing registration and certification organization.
Third Wave’s certification, which was earned after a thorough, independent audit of its quality management system, facilitates the company’s CE marking of products for sale in Europe. It also is recognized by Canadian regulatory authorities as being in compliance with that country’s quality requirements. To earn ISO 13485:2003 certification, a company must implement and document strict quality management processes for product development and delivery, employee training, and materials purchasing, among others.
“This important certification strengthens Third Wave’s ability to broaden our markets and reflects the company’s ongoing commitment to quality in the design, manufacture and support of nucleic acid reagents and tests,” said John Puisis, president and chief executive officer of Third Wave. “Third Wave’s quality system allows the company to continuously improve and remain at the cutting edge of the in vitro diagnostic, or IVD, industry. Our ISO 13485:2003 certification demonstrates clearly the commitment of every employee at Third Wave to product quality and customer satisfaction.
“Achieving certification to the new quality system standard puts Third Wave ahead of those IVD companies that are currently registered to the older 13485:1996 standard,” Mr. Puisis said.
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(R) 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(R) 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 http://www.twt.com .
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 technological approaches of Third Wave and its competitors, product development, manufacturing, market acceptance, cost and pricing of Third Wave products, dependence on collaborative partners and commercial 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 http://www.sec.gov . 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.