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Third Wave submits 510(k) to U.S. FDA for cystic fibrosis molecular test

Published in Medical Letter on the CDC and FDA, February 4th, 2007

Third Wave Technologies Inc. (TWTI) announced that it has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for its InPlex cystic fibrosis molecular test.

The InPlex test submitted to the FDA is designed to simultaneously detect and identify mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in genomic DNA samples isolated from human whole peripheral blood specimens. This test is a qualitative genotyping test intended to provide information to determine CF carrier status in adults, as an aid in newborn screening and in confirmatory diagnostic testing in newborns and children. The results of a...

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