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