The U.S. Army Medical Research Acquisition Activity (USAMRAA) in support of the U.S. Army Medical Research and Materiel Command (USAMRMC), Combat Casualty Care Research Program (CCCRP), intends to issue a cost-plus fixed-fee contract for the development of an FDA approved Bench-top Traumatic Brain Injury (TBI) Diagnostic Assay System, a Point-of-Care TBI Diagnostic Assay System, and a Hand-held (for example, Lateral Flow Strip Based) TBI Diagnostic Assay System. Successful contractor performance must include validated Phase I and Phase II human data for at least two biomarkers with at least one of the two biomarkers demonstrating the following ability: to detect severe TBI via patient blood serum with a specificity of at least 90% and a sensitivity of at least 80% within 6 hours of injury; to detect a mild TBI via patient serum with a specificity of at least 90% and a sensitivity of at least 75% within 6 hours of injury; and to predict mortality in severe TBI patients with a specificity of greater than 95% and a sensitivity of at least 80% within 12 hours after injury. The biomarker S100B will not be considered due to the nature of military trauma which involves multiple injuries to tissues and organs that can release S100B and thus confound its specificity as a marker of brain trauma. The major tasks for this contract will be to establish clinical trial centers for the pivotal trial; prepare an application to the FDA for Investigational Device Exemption (IDE) of a Bench-top TBI Diagnostic Assay System; to initiate and obtain Institutional Review Board (IRB) approvals with trial sites and the U.S. Army Medical Research and Materiel Command Human Research Protections Office; to perform the pivotal trial on the Bench-top TBI Diagnostic Assay System; to develop GMP manufacturing methods for reagents required for the pivotal trial; and to obtain FDA regulatory approval for a Point-of-Care TBI Diagnostic Assay System as well as a Hand-held TBI Diagnostic Assay System for use by military medics on the battlefield. The key deliverables for this contract are a successful pivotal trial and PMA filing with the FDA to achieve FDA clearance for the proposed contractor's biomarker assays performed on the Bench-top TBI Diagnostic Assay System and eventually for a Point-of-Care TBI Diagnostic Assay System and a Hand-held TBI Diagnostic Assay System. PROPOSED MODIFICATION: The Statement of Work is being modified to utilize 40 testing sites rather than 30. This modification will allow for faster patient enrollment which in turn is estimated to speed up the scheduled completion of the clinical trial by approximately 6 months. This schedule improvement is advantageous to the Government because it provides a lacking critical technology to the warfighter sooner than projected. The impact of receiving this technology early is evident in its intended role by improving the quality of care given to soldiers, possibly saving lives, and reducing overall costs of treatment. USAMRAA intends to negotiate this contract on a sole source basis with Banyan Biomarkers, Inc in accordance with Federal Acquisition Regulation (FAR) Part 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. This notice is not a request for a competitive quote. Competing this requirement and awarding to any other manufacturer and system would result in substantial delays and disruption of several key projects already in progress and would also increase the overall cost to the government. Any response to this notice must be submitted in writing to the Government and show clear and convincing evidence that another source is capable of meeting the Government's requirements and that competition of the requirement would be advantageous to the Government. If no written responses are received at least fifteen (15) days after the publication of this response, the purchase will be awarded without further notice. Questions and comments pertaining to this procurement shall be emailed to
[email protected].