DNA-Based Cystic Fibrosis Test Wins FDA Approval
The first DNA-based blood test to detect cystic fibrosis has been approved by the U.S. Food and Drug Administration.
The Tag-It Cystic Fibrosis Kit, produced by the Tm BioScience Corp. of Toronto, Canada, identifies genetic variations that can help diagnose the condition in children and identify adults who may be carriers of the disease, the FDA said in a statement.
The test does not identify all of the more than 1,300 genetic variants that could contribute to the disease, the agency said, in recommending that the test not be the only method used to identify cystic fibrosis.
Cystic fibrosis is the leading cause of chronic lung disease in children and young adults, the FDA said, affecting about 1 in 2,500 Caucasian babies. Half of its victims die before their 30th birthday.
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