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FDA approves cystic fibrosis test

The US Food and Drug Administration (FDA) have approved Tag-ItTM (Tm Bioscience Corp.) for the detection of cystic fibrosis. It is the first test of its kind to use genetic data from a blood sample to diagnose the lung disorder, which affects approximately one in 2500–3300 Caucasian babies. A recently published study demonstrated that Tag-It can identify gene abnormalities that can cause the disease, “with a high degree of certainty,” the FDA said in a statement. According to the FDA, more than 1300 variations in the cystic fibrosis transmembrane conductance regulator gene can be used to identify patients with cystic fibrosis. Tm Bioscience’s test can pinpoint “a limited number” of gene variations and should not be the only test used, the FDA said. Doctors should also take in account patients’ family histories, ethnic background and health, agency officials added. Tm Bioscience’s testing kit, “will be used to help diagnose cystic fibrosis in children and to identify adults who are carriers of the gene variations,” the FDA said.