Att-SOW-75N95024Q00261.pdf

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Biomarker analysis in cerebrospinal fluid samples (CSF) and plasma
Solicitation number
75N95024Q00261
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This document is a Statement of Work (SOW) for a federal contract opportunity to perform biomarker analysis on cerebrospinal fluid (CSF) and plasma samples. The National Institute on Aging (NIA) Center for Alzheimer's Disease and Related Dementias (CARD) requires the contractor to analyze approximately 2,000 CSF samples for specific biomarkers related to Alzheimer's disease and related dementias, including A-beta 40, A-beta 42, neurofilament light (NfL), glial fibrillary acidic protein (GFAP), and phosphorylated tau 217 (pTau217). The period of performance is 12 months, and the government will provide the CSF samples. The contractor must deliver raw data via a Google Cloud server and provide weekly progress reports. The contract will be awarded as a firm fixed-price purchase order, and the solicitation is a full and open competition with no set-aside restrictions.

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Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

Statement of Work - GENERAL INFORMATION Title of Project:

Biomarker analysis in cerebrospinal fluid samples (CSF) and plasma.

Statement of Need and Purpose:

The National Institute on Aging (NIA) 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). Commercial CSF/plasma tests for Aβ40, Aβ42, NfL, GFAP, and pTau217 have recently been developed to use as potential early detection tools for Alzheimer’s Disease. Identifying biomarker profiles of these proteins in non-affected and disease samples will advance our understanding of ADRD.

Background Information and Objective:

Tau proteins are essential for maintaining the stability of neuronal microtubuals in the brain.

Abnormal phosphorylation of tau can lead to the formation of neurofibrarillary tangles, which are a hallmark of Alzehimer’s disease. Additionally, filament proteins Neurofilament light (NfL) and Glial Fibrillary Acidic Protein (GFAP) have shown to be associated with ADRD. Amyloid plaques observed in the brains of indiviuals affected with Alzheimer’s Disease are composed of many proteins, most notably Aβ40 and Aβ42 peptides. Analysis of these biomarkers: Aβ40, Aβ42, NfL, GFAP, and pTau217 will advance the understanding of multiple ADRD. The findings associated with this project could prove valuable for early detection and secondary prevention of ADRD.

Period of Performance:

12 months

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 perform Fujirebio Lumipulse G1200® Aβ40 Biomarker assay on 2000 CSF and samples.

• Contractor shall perform Fujirebio Lumipulse G1200 Lumipulse® Aβ42 Biomarker assay on 2000 CSF samples.

• Contractor shall perform Quanterix Simoa® N2PB (NfL & GFAP) Biomarker assay on 2000 CSF samples.

• Contractor shall perform Quanterix Simoa® pTau217 Biomarker Assay on 2000 CSF samples.

• Contractor shall in included pooled plasma reference (PPR) samples on each analysis plate for the Quanterix instrument and on each run day for the Fujirebio instrument to monitor assay performance.

• Unused Government samples shall be securely stored at -80 and shipped back to Government at completion of the project.

LEVEL OF EFFORT

Contractor shall provide the assay results via reporting transfer through email.

GOVERNMENT RESPONSIBILITIES

Government will provide 2000 CSF samples

DELIVERY OR DELIVERABLES

Raw data 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.

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

SCOPE OF WORK
DELIVERY OR DELIVERABLES

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