Luminex (LMNX) Receives 510k Clearance From FDA for a New Cystic Fibrosis Test
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Luminex Corporation (NASDAQ: LMNX) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new cystic fibrosis (CF) test: the xTAG(R) Cystic Fibrosis 39 Kit v2.
Designed with years of feedback from clinicians and technicians, the newly cleared xTAG test detects for 39 CF-causing gene mutations. It is used to screen potential parents to determine if they are carriers of CF-causing gene mutations, and as an aid in newborn screening and in confirmatory diagnostic testing in newborns and children.
The xTAG Cystic Fibrosis 39 Kit v2 is uniquely flexible, offering physicians the ability to select the CFTR gene mutations for which they want to test. Doctors can choose to test a patient for the 23 ACMG/ACOG-recommended gene mutations or the entire panel of 39 CFTR gene mutations. [SM]
Designed with years of feedback from clinicians and technicians, the newly cleared xTAG test detects for 39 CF-causing gene mutations. It is used to screen potential parents to determine if they are carriers of CF-causing gene mutations, and as an aid in newborn screening and in confirmatory diagnostic testing in newborns and children.
The xTAG Cystic Fibrosis 39 Kit v2 is uniquely flexible, offering physicians the ability to select the CFTR gene mutations for which they want to test. Doctors can choose to test a patient for the 23 ACMG/ACOG-recommended gene mutations or the entire panel of 39 CFTR gene mutations. [SM]
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