JM27-116 funds increase for existing contract # 226354 - Substrates and Internal Standards for MPS-I and Pompe Disease screenings

The Utah Department of Health and Human Services (DHHS), through the Division of Purchasing, is seeking to increase funding for existing Contract #226354 with Enfanos for substrates and internal standards used in newborn screening for MPS-I and Pompe Disease, with notice posted September 24, 2026 and a public-challenge period closing October 2, 2026. This is a non-competitive sole-source award; the Division of Purchasing must determine that only one source exists for the procurement item or that transitional costs and operational circumstances make standard procurement impractical and not in the state's best interest.

The scope comprises GAA-IDUA assay substrates, GAA-IDUA assay internal standards, and 2-plex assay buffer reagents (pH 4.7) supplied in lyophilized form (substrates and internal standards) and liquid form (buffer). Annual volume is approximately 600 vials of each component; one vial of each is sufficient for 100 screening assays. Deliverables include purity analysis and quantitative concentrations performed by quantitative NMR (qNMR). Shipments are delivered quarterly or on request, with 48-hour advance notice required if the contractor cannot meet expected dates.

The contract amendment increases total value from $350,000 to $466,000 — a $116,000 increase — with the existing contract term ending April 17, 2027. Unit pricing is $166.667 per combined substrate, internal standard, and buffer vial. The original contract was awarded under solicitation NH22-60. The DHHS justifies the non-competitive award by citing increased demand for Pompe Disease testing, proprietary formulations and manufacturing processes held solely by Enfanos, and significant transitional costs and operational disruption that would result from changing vendors.

Interested vendors may file a public challenge during the notice period by submitting documentation of alternative qualified sources and comparable pricing, along with detailed explanations and cost comparisons. All vendors must certify compliance with Utah Code 63G-27 et seq., confirming no economic boycotts or boycotts of the State of Israel.