March 15, 2008 — Third Wave Technologies Inc. has received clearance from the US Food and Drug Administration of its InPlex CF Molecular Test. The test simultaneously detects and identifies cystic fibrosis mutations in patient DNA samples. The InPlex CF Molecular Test delivers the accuracy of Third Wave’s Invader chemistry in a microfluidic card developed in collaboration with 3M Co.
In studies submitted to the FDA as part of the company’s clearance application, the test achieved 100% agreement on cystic-fibrosis positive samples and 99.96% overall agreement when compared to DNA sequencing, the standard for genotype determination.
This genotyping test provides information for cystic fibrosis carrier screening for adults of reproductive age as recommended by the American College of Medical Genetics (ACMG) and the 2005 American College of Obstetrics and Gynecology (ACOG), as an aid in newborn screening for cystic fibrosis, and in confirmatory diagnostic testing for cystic fibrosis in newborns and children. The test panel includes mutations and variants recommended by the 2004 ACMG.
“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,” says Dr. Monique Johnson, research assistant professor in the Department of Molecular and Medical Genetics at Oregon Health and Science University. “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.