This is a firm-fixed price contract awarded by the U.S. Army Medical Research Acquisition Activity (USAMRAA) to Abbott Laboratories Inc., a subsidiary of the larger Abbott Laboratories corporation. The contract, valued at $13,548,494.28, is for the development of an Food and Drug Administration (FDA) approved assay cartridge for the i-STAT point-of-care device. The cartridge is intended to screen for the presence of two protein biomarkers, Ubiquitin Carboxy-Terminal Hydrolase-L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP), which are associated with traumatic brain injury (TBI). The key objectives include manufacturing the assay cartridge, conducting applicable clinical trials, and securing FDA approval for the TBI point-of-care platform. This sole-source contract was awarded without a set-aside designation, as Abbott Laboratories is the sole manufacturer and provider of the i-STAT device. The ultimate completion date for the contract is March 31, 2021.
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