A--Notice of Intent to Procure via Sole Source Development and FDA Clearance or Approval of a Traumatic Brain Injury Diagnostic Assay Using Ortho Clinical Diagnostics VITROS(r) 350 Device
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The United States Army Medical Research Acquisition Activity (USAMRAA) intends to award a sole source cost-type contract to Ortho Clinical Diagnostics (a Division of Johnson and Johnson) for the development and FDA clearance or approval of a diagnostic assay for traumatic brain injury (TBI). This assay will utilize the OCD/JJ Vitros 350 device alongside Banyan Biomarkers UCHL1 and GFAP protein biomarkers to screen serum samples to detect the presence or absence of TBI. The contract is planned for a five-year period, consisting of a base year plus four option years. This notice serves as an Intent to Procure and is not a solicitation for competitive proposals. Interested and responsible parties may submit capability information by February 27, 2013, to demonstrate their ability to fulfill the requirement; however, the government retains the sole discretion to decide whether to pursue a competitive procurement based on the responses received. No costs related to responses will be reimbursed, and inquiries are to be submitted exclusively via email. This procurement falls under NAICS code 541711, related to research and development in the physical, engineering, and life sciences. The government emphasizes that telephonic inquiries will not be accepted.
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