D - Statement of Work.pdf

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

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Plasma assays of Alzheimer’s disease biomarkers (abeta42, abeta40, ptau217 ) using the Lumipulse assays on the Fujirebio G1200 in the Baltimore Longitudinal Study of Aging (BLSA) Statement of Need and Purpose:

The National Institute on Aging (NIA) requires quantification of the-state-of-art assays for plasma abeta42, abeta40, ptau217 using Lumipulse assays. These biomarkers will be assayed using stored specimens from participants in the Baltimore Longitudinal Study of Aging (BLSA).

This procurement is for the services of the Senior research specialist to perform the Lumipulse assays on the Fujirebio G1200 instrument.

Background Information and Objective:

Evidence from autosomal dominant Alzheimer’s disease (AD) research suggests that soluble forms of phosphorylated tau may have downstream effects on neurodegenerative processes and cognitive decline. Recent data suggest that pTau217 may be particularly sensitive to the development of brain amyloid. The purpose of this procurement is to perform assays for biomarkers of AD (ABeta, pTau217) in longitudinal biospecimens from participants in the BLSA who have scores on the phenotypic metric of aging index or proteomics data. These data will be used by investigators in the Laboratory of Behavioral Neuroscience and Translational Gerontology Branch to leverage the wealth of available neuroimaging, cognitive, and clinical data in the BLSA. Specifically measures of ABeta and pTau217 will be used to stratify participants to determine the likelihood that participants are in a preclinical phase of AD. These measures will also be used continuously alone and in combination with biomarkers of inflammation and neuronal injury to further understand the causes of cognitive and brain changes in healthy individuals and those with a variety of comorbidities. This project requires the use of high throughput equipment and sensitive assays for the identification of these biomarkers. For continuity of research, the assays must be performed in a similar way to prior assays in serum/plasma from BLSA participants. The contractor shall build upon assessments already performed. These biomarkers will provide important insights into the biological underpinnings of cognitive impairment and AD/Alzheimer’s Disease and Related Dementias (ADRD) years before any symptoms would be apparent. New insights may lead to early identification of those most likely to show cognitive decline, as well as novel treatments to help prevent or delay AD/ADRD.

Period of Performance:

May 1, 2025, to April 30, 2026.

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 analyze serum/plasma of abeta42, abeta40, and pTau 217 using Lumipulse assays on 4000 samples from BLSA study participants. The contractor will use senior research specialists to perform the assays on the Fujirebio G1200 analyzer. The data shall be compiled and sent to the NIA after completion of the assays.

LEVEL OF EFFORT:

N/A

GOVERNMENT RESPONSIBILITIES

The government will provide the serum/plasma samples to be assayed and the necessary kits and materials to perform the assays.

DELIVERY OR DELIVERABLES

The contractor shall deliver an electronic copy of the results of the analysis within one (1) year from the date of receipt of the contract.

REPORTING REQUIREMENTS

The contractor shall provide a written progress report once the samples have been analyzed that will cover measurements for each sample, problems encountered, problem resolution, and unresolved problems.

OTHER CONSIDERATIONS

Travel:

N/A

Information System Security Plan:

N/A

Data Rights:

The National Institute on Aging shall have unlimited rights to and ownership of all deliverables provided under this contract including reports, recommendations, briefings, work plans and all other deliverables. This includes the deliverables provided under the basic contract and any optional task deliverables exercised by the contracting officer. In addition, it includes any additional deliverables required by contract change. The definition of “unlimited rights” is contained in Federal Acquisition Regulation (FAR) 27.401, “Definitions.” FAR clause 52.227-14, “Rights in Data-General, ” is hereby incorporated by reference and made a part of this contract/order.

Section 508—Electronic and Information Technology Standards:

N/A Publications and Publicity:

The contractor shall work with the National Institute on Aging on publications. Any publications are required to follow the National Institute on Aging publication procedures.

Confidentiality of Information:

N/A