Third Wave's cystic fibrosis test gets FDA clearance

Madison, Wis. - Third Wave Technologies has received clearance from the U.S. Food and Drug Administration for its cystic fibrosis genotyping test, the company's second major FDA approval in the past week.

The Cystic Fibrosis test, known as InPlex, simultaneously detects and identifies cystic fibrosis mutations in patient DNA samples. Now employed by more than 70 labs, the test uses a combination of Third Wave's Invader chemistry and a microfluidic card developed in collaboration with 3M Co.

Cystic fibrosis, the most common inherited disease in North America, is a fatal genetic disease that affects more than 30,000 Americans. Testing for cystic fibrosis provides critical information about parents' carrier status, and aids in the early diagnosis of newborns.

Kevin Conroy, president and chief executive of Third Wave, estimated the test would enable Third Wave to expand its 15 percent cystic fibrosis market share and further establish itself in the $270 million genetic and pharmacogenetic testing market.

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