Newborn Screening Pilot Studies

The National Institutes of Health established this Master IDIQ on September 28, 2015, to operate a pool of high-throughput newborn screening laboratories capable of rapidly developing protocols and initiating pilot testing when new conditions are added to the Recommended Uniform Screening Panel. Ordering against this vehicle closed on September 28, 2020, and the vehicle is no longer active.

Nine task orders totaling $4 million in combined potential value were issued over the vehicle's five-year ordering window. All obligated value ($4 million, representing 100 percent of the combined potential value) has been committed; no remaining capacity exists. Award activity concentrated in the first two years: three orders in 2015 and two in 2016, with the remaining four orders spread across 2017, 2019, and 2020 at a rate of roughly one per year thereafter.

Task orders span pilot studies for specific metabolic and genetic disorders: spinal muscular atrophy (SMA), adrenoleukodystrophy (ALD), homocystinuria-related disorders (expanded HCU), proximal urea cycle disorders (PUCD), and mucopolysaccharidosis type I (MPSI). Work was conducted on a cost basis, either Cost No Fee or Cost Plus Fixed Fee.

Three academic institutions hold all awards. Emory University captured five orders valued at $2.3 million combined, while Research Triangle Institute holds three orders worth $1.7 million. University of Massachusetts Medical School received one order for $5 thousand. The National Institute of Child Health and Human Development funded eight orders ($3.5 million), with the National Institute of Diabetes and Digestive and Kidney Diseases funding one order ($509 thousand).

All nine task orders were unrestricted competitive awards. Individual order values ranged from $5 thousand to $783.5 thousand, with completion dates extending into 2025 on the most recent order. This vehicle presents no current pursuit opportunity due to closed ordering status and full obligational commitment.

The purpose of this Master IDIQ is to create a pool of high throughput newborn screening laboratories with the capacity to screen a large number of newborns in relatively short periods of time that are representative of various regions of the United States. The selected Contractors will operate under an IDIQ Task Order contract to rapidly develop protocols and initiate testing shortly after the addition of a new condition to the Recommended Uniform Screening Panel (RUSP).