FDA Allows Marketing of Newborn SCID Screening Test

The FDA will allow marketing of the EnLite Neonatal TREC Kit, a screening test for severe combined immunodeficiency (SCID) in newborns.​

SCID is a group of genetic disorders that hinder the development of T cells and other infection-fighting cells, crippling the body’s immune system. While newborns with SCID initially appear normal, they are susceptible to life-threatening infections within a few months, and they may die within their first year without early intervention and treatment.

The EnLite Neonatal TREC Kit analyzes a newborn’s blood to determine whether the newborn has a sufficient amount of a type of DNA known as a T-cell receptor excision circle (TREC), which is typically deficient or absent in newborns with SCID. While this test provides an important look at a newborn’s TREC DNA count, additional testing would still be required before a newborn could be formally diagnosed with SCID.

During the FDA’s review, the EnLite Neonatal TREC Kit correctly identified all 17 cases of SCID in a sample of approximately 6400 blood spot specimens. The FDA also evaluated the EnLite Neonatal TREC Kit’s ability to distinguish low TREC DNA counts from high ones, and it found that the test accurately detected low values.

The Secretary of the US Department of Health and Human Services and the Advisory Committee on Heritable Disorders in Newborns and Children recommend that every state screen newborn infants for SCID, as well as other genetic, endocrine, and metabolic disorders. To date, 25 states, the District of Columbia, and the Navajo Nation have implemented SCID screening programs, with some states requiring that their newborn screening programs use a test that has been approved or cleared by the FDA.

Approximately 40 to 100 new cases of SCID are identified in newborns in the United States every year, according to the US Centers for Disease Control and Prevention.