FDA Allows Marketing of the First Newborn Screening Test to Help Detect Severe Combined Immunodeficiency

Silver Spring, Maryland–(ENEWSPF)–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 to100 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…