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FDA allows marketing of neonatal SCID screening test
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The FDA announced it has allowed marketing of the EnLite Neonatal TREC Kit, a screening test for severe combined immunodeficiency in neonates.
The screening test, manufactured by Wallac Oy, a subsidiary of PerkinElmer, can determine if T-cell receptor excision circles (TREC DNA) are low or missing from an infant’s blood using samples taken from the child’s heel.
The EnLite Neonatal TREC Kit was reviewed through the FDA’s de novo classification process.
A clinical study including approximately 6,400 blood spot specimens from infants determined efficacy of the screening test. Seventeen of the study participants were diagnosed with severe combined immunodeficiency (SCID) and the screening test detected all 17 cases of SCID, according to the FDA.
Further FDA testing indicated the EnLite Neonatal TREC Kit adequately detected very low TREC DNA values associated with SCID in neonates.
“SCID is a fatal disease that can be treated with early intervention, including screening,” Alberto Gutierrez, PhD, director of the FDA’s office of in vitro diagnostics and radiological health, said in a press release. “For the first time, the FDA is allowing the marketing of a newborn screening test that will enable states to incorporate an FDA-reviewed SCID test into their standard newborn screening panels and allow earlier identification for affected individuals.”
Sylvia M. Burwell
Sylvia M. Burwell, secretary of the US Department of Health and Human Services, and the Advisory Committee on Heritable Disorders in Newborns and Children recommend every US state screens neonates for SCID in addition to other genetic, endocrine and metabolic disorders. Currently, 25 states, the District of Columbia and the Navajo Nation have screening programs for SCID.
The EnLite Neonatal TREC Kit is not intended as a diagnostic method for SCID or as a screening test for SCID-like syndromes, such as DiGeorge Syndrome or Omenn Syndrome, or less acute SCID syndromes like leaky SCID or variant SCID, according to the release.