DNA-based CF diagnostic test available
NEWS IN BRIEF — Posted June 6, 2005
The Food and Drug Administration last month approved the first DNA-based blood test to aid in cystic fibrosis diagnosis. The Tag-It Cystic Fibrosis Kit can detect variations in the cystic fibrosis transmembrane conductance regulator gene that cause many cases of this disease.
"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, MD, director of the FDA's Center for Devices and Radiological Health.
Because the test does not detect all genetic variations responsible for the disease, the agency recommends that results only be used for diagnosis in conjunction with a physician's interpretation of the patient's clinical condition, ethnicity and family history.
The test can also be used to detect carriers of these genetic variations.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2005/06/06/hlbf0606.htm.