First neonatal SCID screening test approved by FDA

First neonatal SCID screening test approved by FDA
First neonatal SCID screening test approved by FDA

The Food and Drug Administration (FDA) has granted marketing of the EnLite Neonatal TREC Kit, the first FDA-cleared test to screen for severe combined immunodeficiency (SCID) in newborns.

The EnLite Neonatal TREC Kit requires a few drops of blood from the newborn's heel. After it has dried on filter paper, the Kit can detect whether the T-cell receptor excision circles (TREC DNA) are low or missing from the newborn's blood sample. TREC DNA is a specific type of DNA that is normally absent or present in low amounts in newborns with SCID compared to healthy infants. Further testing is necessary to confirm a SCID diagnosis.

The FDA reviewed a clinical study of about 6,400 blood spot specimens from routine newborn screening, of which 17 had confirmed SCID. The EnLite Neonatal TREC Kit correctly determined all 17 SCID samples. It was also found that the kit could detect very low TREC DNA values associated with SCID.

Every state is recommended by the U.S. Department of Health and Human Services to screen newborns for SCID as well as other genetic, endocrine, and metabolic disorders.

Loading links....
You must be a registered member of Clinical Advisor to post a comment.

Sign Up for Free e-newsletters