Category Archives: FDA

The FDA clears the first-ever newborn test to detect Severe Combined Immunodeficiency.

The U.S. Food and Drug Administration (FDA) has cleared the EnLite Neonatal TREC Kit for the company PerkinElmer, 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

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