FDA Allows Marketing of the First Newborn Screening Test to Help Detect Severe Combined Immune Deficiency.
The FDA is giving newborn children around the world a wonderful holiday present by allowing the marketing of the EnLite Neonatal TREC Kit, the first screening test that has been allowed to be marketed by FDA for Severe Combined Immune Deficiency (SCID) in newborns. With the seriousness and severity of SCID diagnoses, it is very encouraging that the FDA has approved this potentially lifesaving screening test.
The FDA’s evaluation included a clinical study of approximately 6,400 blood spot specimens from routine screening of newborns, 17 of which had confirmed SCID diagnosis. The EnLite Neonatal TREC Kit correctly identified all 17 SCID cases. The agency also assessed the test’s ability to accurately distinguish low TREC DNA numbers that would be observed in newborns with SCID, from high TREC DNA numbers that would be present in healthy newborns.
IDF is thrilled that, with this decision, newborn screening for SCID has become more accessible to states around the country
Click here to read the FDA’s full press release.