03 Jan Third Wave seeks approval of Cystic Fibrosis test
Madison, Wis. – Third Wave Technologies, Inc., a manufacturer of molecular diagnostic products, has submitted an application to the U.S. Food and Drug Administration for approval of a new Cystic Fibrosis molecular test.
The test product, which Third Wave calls InPlex, is a genotyping test to determine Cystic Fibrosis carrier status in adults, and to aid in newborn screening and in diagnostic testing in newborns and children. Cystic Fibrosis is a hereditary disease caused by a gene mutation, and the test is designed to detect and identify gene mutations and variants.
The application submitted by Third Wave, which is known as a 510(k) application, is a way to help companies get their products on the U.S. market faster.
According to Third Wave, the Cystic Fibrosis molecular test fared well in performance tests conducted in a multi-center clinical trial.
Cystic Fibrosis causes progressive disability and early death. It affects approximately 30,000 children and adults in the U.S., and it occurs in one of every 2,500 to 3,300 live births among caucasians. There is no cure, but treatments have been developed to slow its progression.
Third Wave has developed several products based on its Invader chemistry for clinical testing. The company develops molecular diagnostic reagents – substances that are part of a chemical reaction used to detect or measure another substance – for DNA and RNA analysis, and it markets in vitro diagnostic kits.
In recent quarters, the company has reported growing revenue from its molecular diagnostic products, which helped reduce its quarterly net loss to $5.2 million in Q3 of 2006. In December, the company announced it had signed an agreement with an institutional investor that could provide it with $14.9 million through the private placement of convertible notes.
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