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Cystic Fibrosis Genetic Testing

The Tag-It™ Cystic Fibrosis Kit is the first FDA-approved DNA-based blood test that helps detect cystic fibrosis. Genetic testing detects a limited number of the 1,300 genetic variations in the CFTR gene. Therefore, this type of testing should not be used alone in making a diagnosis of cystic fibrosis.

An Introduction to Genetic Testing for Cystic Fibrosis

The Food and Drug Administration (FDA) has approved the first DNA-based blood test to help detect cystic fibrosis (CF). It is called the Tag-It™ Cystic Fibrosis Kit. This test analyzes human DNA to find genetic variations that may indicate cystic fibrosis. 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 identifies a group of variations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, which is the cause of cystic fibrosis. The FDA approved this test based on a study of hundreds of DNA samples. These samples were able to show that the test identifies the CFTR gene variations with a high degree of certainty.

Limitations of Cystic Fibrosis Genetic Testing

Genetic testing detects a limited number of the more than 1,300 genetic variations identified in the CFTR gene. Therefore, this genetic test should not be used alone to diagnose cystic fibrosis. Physicians should interpret test results in the context of a patient's clinical condition, ethnicity, and family history. Also, patients may need to get genetic counseling to help them understand their test results.
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