Rat Blood Biomarker Analysis Services - Notice of Intent
This is a notice of intent to issue an award on the basis of other than full and open competition in accordance with the Federal Acquisition Regulation (FAR) 6.302-1, only one responsible source and no other supplies of services will satisfy agency requirements.
The US Army Medical Research Acquisition Activity (USAMRAA) The U.S. Army Medical Research Acquisition Activity (USAMRAA) intends to issue a single source award to Quanterex Corporation, 113 Hartwell Avenue, Lexington, MA 02421.
1. Background: Emerging data suggests that biomarkers of brain injury have potential utility as diagnostic, prognostic, and therapeutic adjuncts in the setting of Traumatic Brain Injury (TBI). Four unique biochemical markers of neuronal, glial, and axonal damage (NF-L, tau, GFAP and UCH-L1) are readily detectable in biological samples such as serum or cerebrospinal fluid and are being studied in patients with TBI. To support this effort, USARIEM has the requirement for biomarker analysis services in rat blood. The product (report) will allow USARIEM to compare measurement levels and inter-individual variations between experimental and control animals, and to perform a comprehensive examination of numerous pathways and biological systems involved in TBI.
2. Requirements:
A) General Requirements.
The contractor shall provide kits and consumables and rat blood biomarker analyses to support preclinical research into mild TBI, and ongoing protocols at USARIEM.
Biomarker analysis of protocol plasma/sera is required so that researchers are able to identify analytes (proteins and small molecules) collected from animals used in the conduct of a USARIEM research protocol titled "Dietary approaches to enhance neuroprotection against mild traumatic brain injury in the rat". The contractor will be required to provide support in accordance with the tasks specified below:
B) Specific Requirements: The contractor shall provide kits, consumables and analysis
services of USARIEM provided samples to include:
a. Accelerator Consumables Kit - all materials required to run four 96-well plates, including discs, tips, cuvettes, buffers, and sealing oil.
b. Neurology 4-Plex A Kit (containing NF-L, tau, GFAP, and UCH-L1) - for running four 96-well plates of a Simoa 4-plex assay.
c. Data analysis - includes running of four plates in the Simoa Accelerator, data analysis, report, quality control procedures, and data review.
d. Contractor shall be available to answer USARIEM questions regarding sample
analysis.
3. Qualifications:
A) General Experience. The contractor shall have expertise as a chemical analytical
laboratory.
B) Specialized Experience: The Contractor must provide comprehensive protein
biomarker services based on a Multi-Analyte Profiling (MAP) technology platform. This platform provides pre-clinical and clinical researchers with reproducible and quantitative data for a few or hundreds of proteins in a cost-effective manner.
Contractor must participate in an external proficiency testing program organized by the College of American Pathologists (CAP) as well as internal proficiency testing. Contractor's assay validation shall be guided by Clinical Laboratory Standards based upon the principles of immunoassay. The Simoa Human Neurology 4-Plex A assay (N4PA) measures four important neurology biomarkers in both cerebrospinal fluid (CSF) and blood. The four targets are neurofilament light (NF-L), total tau, glial fibrillary acidic protein (GFAP), and ubiquitin carboxyl-terminal hydrolase L1 (UCH- L1). All four biomarkers have been studied as indicators of TBI severity. Recent reports indicate serum NF-L is a biomarker for mild TBI in amateur boxers and professional hockey players, that plasma tau is related to concussion severity, and that serum GFAP and UCH-L1 can detect mild to moderate TBI. Each assay is developed as a single test to establish the sensitivity and dynamic range necessary for that analyte. Once the assay is optimized, it is ready to be incorporated into a multiplex.
Multiplexed calibrators (8 levels per analyte) and controls (3 levels per analyte) are developed to monitor the assays' performance. Key performance parameters such as lower limit of quantification, precision, cross-reactivity, linearity, spike-recovery, dynamic range, matrix interference, freeze-thaw stability, and short-term sample stability shall be established for every assay.
4. Government Furnished Equipment/Information/Computer Utilization: USARIEM will provide plasma samples collected from 120 rats.
This is not a formal solicitation or request for quote. This synopsis of intent is to give notice of the Government's intent to make a sole source award. Contractors who can provide the USAMRAA with the required services are invited to electronically submit an affirmative, written response indicating a bona fide ability to meet this specific requirement. Responses should appear on company letterhead and include, at a minimum, affirmation of active registration in the System for Award Management (SAM), technical qualifications, past performance references, and any applicable pricing data or information.
All responses should include a point of contact, telephone number, and electronic mail address. Additionally, respondents should indicate whether they are a large business, small business, small disadvantaged business, 8(a) concern, women-owned small business, HUBZone, service disabled veteran-owned small business, or qualify as socially or economically disadvantaged and whether they are U.S. or foreign owned. Responses to this notice will be used to determine the availability of this type of service. All responsible sources may respond to this synopsis and all responses will be considered by the agency. Responses should be furnished electronically to kandy.b.clark.civ@mail.mil and moriah.s.bartlett.civ@mail.mil no later than 1:00 PM Eastern Time, 1 June 2018.
Kandy B. Clark, Contract Specialist, Phone 3016192093, Email kandy.b.clark.civ@mail.mil - Moriah S. Bartlett, Contract Specialist , Phone 3016192579, Email moriah.s.bartlett.civ@mail.mil
