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FDA Allows Marketing of the First Newborn Screening Test to Help Detect SCID

December 15, 2014

The U.S. Food and Drug Administration today allowed marketing of the EnLite Neonatal TREC Kit, the first screening test permitted to be marketed by FDA for Severe Combined Immunodeficiency (SCID) in newborns.

According to the Centers for Disease Control and Prevention, approximately 40 to 100 new cases of SCID are identified in newborns in the United States each year. SCID is a group of disorders caused by defects in genes involved in the development and function of T cells and other infection-fighting immune cells. Babies with SCID appear normal at birth, but typically develop life-threatening infections within a few months. Without early intervention and treatment, death can occur within the baby’s first year; early detection and treatment can markedly improve survival....

Additional details regarding the release can be found linked here.