NEW YORK (GenomeWeb News) - Third Wave Technologies today said that the US Food and Drug Administration has cleared its InPlex cystic fibrosis genotyping test.
The InPlex CF Molecular Test is based on Third Wave's Invader chemistry and a microfluidic card developed in collaboration with 3M.
The company said that in studies submitted to the FDA as part of its clearance application, the test achieved 100 percent agreement on cystic-fibrosis positive samples and 99.96 overall agreement when compared to DNA sequencing.
Third Wave said the test can be used in carrier screening for adults, as an aid in newborn screening for cystic fibrosis, and in confirmatory diagnostic testing for cystic fibrosis in newborns and children.
Kevin Conroy, president and chief executive of Third Wave, said in a statement that around 70 labs are currently using the company’s InPlex analyte specific reagents for CF testing.
Conroy said that FDA clearance for the test will enable the company to expand its presence in the cystic fibrosis market. He estimated that Third Wave currently holds around 15 percent of that market.
Earlier this week, Third Wave submitted its human papillomavirus test to the FDA for approval.