Third Wave Technologies, Inc. Submits 510(k) To FDA For InPlex(TM) Cystic Fibrosis Molecular Test
MADISON, Wis., Jan. 3 /PRNewswire-FirstCall/ -- Third Wave Technologies Inc. today announced that it has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for its InPlex(TM) Cystic Fibrosis Molecular Test.
The InPlex(TM) Cystic Fibrosis Molecular Test submitted to the FDA is designed to simultaneously detect and identify mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in genomic DNA samples isolated from human whole peripheral blood specimens. This test is a qualitative genotyping test intended to provide information to determine CF carrier status in adults, as an aid in newborn screening and in confirmatory diagnostic testing in newborns and children. The results of a multi-center clinical trial sponsored by Third Wave indicate that the InPlex(TM) Cystic Fibrosis Molecular Test exceeds 99.9% for the performance characteristics evaluated.
Cystic fibrosis is the most common autosomal recessive disorder, currently affecting approximately 30,000 children and adults in the United States. It occurs in one in every 2,500 to 3,300 live births among Caucasians. The InPlex(TM) Cystic Fibrosis Molecular Test includes mutations and variants recommended by the American College of Medical Genetics (ACMG), plus other more common and North American-prevalent mutations.
"Third Wave is pleased to announce the submission of a 510(k) application to the FDA for the InPlex(TM) Cystic Fibrosis Molecular Test," said Kevin T. Conroy, president and chief executive of Third Wave. "We are very encouraged by our ability to continually meet our product development goals."
About Third Wave Technologies
Third Wave develops and markets molecular diagnostic reagents for a variety of DNA and RNA analysis applications to meet the needs of our customers. The company offers a number of products based on its Invader(R) chemistry for clinical testing. Third Wave offers in vitro diagnostic kits, and analyte specific, general purpose, and research use only reagents for nucleic acid analysis. 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. Third Wave Technologies, Invader and the Third Wave logo are trademarks of Third Wave Technologies, Inc.
Contact: Rod Hise Third Wave Technologies Inc. 608 663-4010
Third Wave Technologies Inc.CONTACT: Rod Hise, of Third Wave Technologies Inc., +1-608-663-4010
Web site: http://www.twt.com/