The DoD’s Critical Reagent Program (CRP) currently contracts manufacturing and distribution of all Polymerase Chain Reaction (PCR) assays to the Navy Medical Research Center (NMRC).
NMRC produces both the Ebola Zaire Emergency Use Authorization Diagnostic (EZ1 EUA) and Ebola Zaire surveillance assay kits. Both assay kits require a commercial off the shelf (COTS) item available from Life Technologies Corporation, a Thermo Scientific brand.
CRP this week announced a sole source contract to Thermo Scientific for their SuperScript One-Step RT-PCR System with Platinum Taq DNA Polymerase (the SuperScript consumable) required for use in one of the Ebola diagnostic assays. The estimated value of the award is $1,051,280.
The SuperScript consumable required for the EZ1 diagnostic assay kits was included in the pre-Emergency Use Authorization submission to the Food and Drug Administration (FDA). In order to change the consumable, the FDA requires proof of performance through equivalency testing with changed variable (in this case the SuperScript kit). Equivalency testing would cause unacceptable delays to the US Department of Defense Ebola diagnostic testing capability that is already fielded, in use, and increasing in demand.
“At this point in time this technology is the only proven technology compatible with these assay kits. Time consuming (~6 months) equivalency testing would be required in order to identify and test alternate technology,” states the DoD funding announcement.
The DoD noted that the current commercial supplier does not typically produce the consumable in quantities sufficient to meet increased demand resulting from the ongoing Ebola virus disease epidemic. Given these circumstances, the DoD intends to fund the manufacture and subsequent purchase of enough materials to meet current and future requirements from competitive sources.
“The detection capability requiring the SuperScript consumable is critical in the DoD’s ability to detect the BW agent Ebola,” states the announcement. “A supply gap caused by the time it would take to prove equivalency of another consumable would otherwise cripple the Department of Defense’s Ebola detection capability.”
