March 14, 2008—Third Wave Technologies Inc. (NASDAQ: TWTI) announced that the company has received clearance from the U.S. Food and Drug Administration of its InPlex™ CF Molecular Test. The test simultaneously detects and identifies cystic fibrosis mutations in patient DNA samples. The InPlex™ CF Molecular Test delivers the accuracy of Third Wave’s Invader® chemistry in an easy-to-use microfluidic card developed in collaboration with 3M Co. In studies submitted to the FDA as part of the company’s clearance application, the InPlex™ CF Molecular Test achieved 100% agreement on cystic-fibrosis positive samples and 99.96% overall agreement when compared to DNA sequencing, the standard for genotype determination... Third Wave Technologies' Press Release -
Apr 6, 2008
Third Wave’s InPlex CF Molecular Test : FDA Clearance
March 14, 2008—Third Wave Technologies Inc. (NASDAQ: TWTI) announced that the company has received clearance from the U.S. Food and Drug Administration of its InPlex™ CF Molecular Test. The test simultaneously detects and identifies cystic fibrosis mutations in patient DNA samples. The InPlex™ CF Molecular Test delivers the accuracy of Third Wave’s Invader® chemistry in an easy-to-use microfluidic card developed in collaboration with 3M Co. In studies submitted to the FDA as part of the company’s clearance application, the InPlex™ CF Molecular Test achieved 100% agreement on cystic-fibrosis positive samples and 99.96% overall agreement when compared to DNA sequencing, the standard for genotype determination... Third Wave Technologies' Press Release -
