SOW Protein Analysis in Cerebrospinal Fluid Samples.pdf
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- SOURCES SOUGHT: Protein Analysis in Cerebrospinal Fluid Samples (CSF) Federal contract opportunity
- Solicitation number
- 75N95023Q00222
About this file
This document contains a sources sought notice and statement of work for a federal contract opportunity. The National Institutes of Health National Institute on Drug Abuse is seeking protein analysis services on 1,648 cerebrospinal fluid samples to detect the presence or absence of alpha synuclein seeds using the Amprion SYNTap assay. Interested small businesses must have the capability to provide all necessary personnel, materials, equipment, and facilities to complete the work over a one year period of performance. Responses are due by April 28, 2023 and must include company information, NAICS code, and a ten page capability statement addressing each requirement. The contractor will report results weekly and deliver raw data files.
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Text version
Version 11-30-2016-1 FAR Part 11—Describing Agency Needs
GENERAL INFORMATION
Title of Project:
Protein Analysis in Cerebrospinal Fluid Samples (CSF)
Statement of Need and Purpose:
The Center for Alzheimer’s Disease and Related Dementias (CARD) is endevoring on a large-scale phenotyping project to characterize patient samples afflicted with Alzheimer’s Disease and Related Dementias (ADRD). To date, alpha synuclein is traditionally difficult to analyze in CSF. Recently, a new method has been developed to identify misfolded ASyn seeds. Identifying misfoled ASyn protein in CSF will advance our understanding of ADRD.
Background Information and Objective:
Lewy body pathology is one of the co-occurring non-AD pathologies that can contribute to overall clinical and cognitive deterioration, even in cases of dominantly inherited AD. The advent of molecular imaging and fluid-based biomarkers allowed for detection of AD neuropathological changes in living individuals. However, until recently biomarkers have remained mostly unavailable for non-AD neuropathological changes, including Lewy body disease. Without incorporation of biomarkers to recognize the presence and severity of comorbid Lewy body pathology, every clinical trial designed to show the effectiveness of an AD treatment will continue to systematically underestimate the maximum therapeutic effect of the drug. Alpha-synuclein (ASyn) has been identified as a hallmark protein involved in synucleinopathies but accurate detection of pathogenic ASyn has hindered advancements in this area of research. However, recent studies by Soto and colleagues led to the development of a commercial assay (Amprion SYNTap®) for detection of aggregates of misfolded ASyn seeds in CSF. We aim to detect the presence or absence of ASyn seeds by using Amprion SYNTap assay.
Period of Performance:
The anticipated period of performance is 1 year.
SCOPE OF WORK
General Requirements:
Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below.
Specific Requirements:
Contractor shall use SYNTap Biomarker Test using a Seed Amplification Assay (SAA) to determine the absence or presence of alpha synuclein in 1648 samples of CSF.
Unused Government samples shall be securely stored at -80 and shipped back to Government at completion of the project.
LEVEL OF EFFORT
Contractor staff shall provide the assay results via reporting transfer thru email.
GOVERNMENT RESPONSIBILITIES
Government will provide 1648 CSF samples to contractor. Samples will be provided at 500ul volume per sample.
DELIVERY OR DELIVERABLES
Raw data in Excel format delivered by Google Cloud server.
REPORTING REQUIREMENTS
The Contractor shall submit the following reports as specified below. All reports shall be submitted electronically either as a Word document or PDF file or Excel file, as appropriate.
Weekly reports through email related to receival of samples, experimental progress, experimental results, and sample failure, and sample storage.
OTHER CONSIDERATIONS
Travel:
The principal place of performance is the Contractor’s work site. Travel for contractor employees will not be necessary.
Key Personnel:
Contractor will provide a dedicated project manager to the government as a contact point for the services.
Information System Security Plan:
Not applicable.
Data Rights:
The Contractor will be responsible for the transfer of de-identified raw data to the Government.
Data shall be transmitted electronically. The Contractor shall provide consultation on related features of manuscript preparation.
Section 508—Electronic and Information Technology Standards:
The contractor shall comply with Section 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998.
Publications and Publicity:
Not Applicable
Confidentiality of Information:
Not Applicable
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