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Third Wave gets FDA approval for cystic fibrosis test

Staff/news services  —  3/16/2008 7:05 am

Madison-based Third Wave Technologies Inc. said Friday that federal regulators have approved its cystic-fibrosis genetic test.

Third Wave CEO Kevin Conroy said approval from the Food and Drug Administration will allow the company to gain more of the $270 million genetic and pharmacogenetic testing market. It now has 15 percent of that market, he said.

The diagnostics company teamed with 3M Co. to develop a molecular testing card called InPlex CF. The test is administered on adults, children and newborns to find out whether they carry genes for cystic fibrosis.

In studies submitted to the FDA, the test was able to identify 100 percent of samples that carried cystic fibrosis and matched up with standard DNA sequencing test results 99.96 percent of the time, Third Wave said.

Cystic fibrosis carrier screening for adults of reproductive age is recommended by medical authorities as an aid in newborn screening for cystic fibrosis, and in confirmatory diagnostic testing for cystic fibrosis in newborns and children.

"Upon evaluation in our academic-hospital clinical laboratory, we found the InPlex� CF card was sensitive and specific, and required minimal hands-on time and training," Dr. Monique Johnson, research assistant professor in the Department of Molecular and Medical Genetics at Oregon Health and Science University, said in a statement. "With minimal start-to-finish time, the InPlex CF card generated easily-decipherable data and was overall an excellent CF testing platform."

Dr. Johnson is the lead author of "A Comparative Study of Five Technologically Diverse CFTR Testing Platforms," which was published in the Journal of Molecular Diagnostics in July 2007.

"Customers consistently tell us that InPlex CF is the easiest method on the market," Conroy said in a statement. 

Cystic fibrosis is a fatal genetic disease that affects more than 30,000 Americans. It is the most common inherited disease in North America, with one in 31 Americans carrying a cystic fibrosis mutation.

Staff/news services  —  3/16/2008 7:05 am