FDA OKs CF detection kit

ROCKVILLE, Md., May 10 (UPI) -- Food and Drug Administration officials in Maryland have approved the first DNA-based blood test to help detect cystic fibrosis.

The Tag-It Cystic Fibrosis Kit directly analyzes human DNA to find genetic variations indicative of the disease, the FDA said Tuesday. The test will be used to help diagnose cystic fibrosis in children and to identify adults who are "carriers" of the gene variations.

"This test represents a significant advance in the application of genetic technology and paves the way for similar genetic diagnostic tests to be developed in the future," said Daniel Schultz, director of FDA's Center for Devices and Radiological Health. The kit is made by Canada's Tm Bioscience Corp. of Toronto, Ont.

Cystic fibrosis is a serious genetic disorder affecting one's lungs and other organs and often results in an early death. It is the main cause of chronic lung disease in children and young adults, as well as the most common fatal hereditary disorder affecting Caucasians in the United States.

The disease affects about one in 2,500 to 3,300 Caucasian babies. Half of cystic fibrosis victims die by the age of 30.