Third Wave Technologies Inc.

Third Wave Technologies Inc. announced that the company has received clearance from the U.S. Food and Drug Administration of its InPlex(TM) CF Molecular Test. The test simultaneously detects and identifies cystic fibrosis mutations in patient DNA samples. The InPlex(TM) CF Molecular Test delivers the accuracy of Third Wave's Invader(R) 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(TM) 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.