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FDA approves Third Wave’s molecular test

US based Third Wave Technologies has received clearance from the FDA for InPlex CF molecular test.

The test simultaneously detects and identifies cystic fibrosis (CF) 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 Company.

Kevin Conroy, president and CEO of Third Wave, said: “We believe the clearance of the InPlex CF Molecular Test will enable Third Wave to expand our 15% cystic fibrosis market share and further establish our leadership in the $270-million genetic and pharmacogenetic testing market.”