Attachment 1 - Statement of Work.pdf

Attachment 1

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

An analysis of the cerebral spinal fluid and plasma proteome in Alzheimer’s disease

Statement of Need and Purpose:

The purpose of this requirement is to apply a multiplexed assay of targeted biomarkers for central nervous system (CNS) disease to archived cerebral spinal fluid (CSF) and plasma specimens of participants with Alzheimer’s disease, and healthy young, middle-aged, and older adults. The contract will examine how the relationship between plasma and CSF levels of the same protein correspond to each other across each of these three participant groups. It will also examine the association of plasma and CSF protein levels with measures of cognition and clinical status (e.g., cognitively normal vs. dementia). Targeted biomarkers measured in this element of the project will be used to classify and stage individuals with Alzheimer’s disease.

Background Information and Objective:

Despite the rapid growth of plasma proteomic approaches in neuroscience research, it remains unclear the extent which the level of specific proteins, as measured in blood, relate to levels of the same proteins measured in the central nervous system (CNS), i.e., in cerebral spinal fluid (CSF). Furthermore, it is not known to what extent age and disease status affect these protein-protein relationships. Here, the National Institute on Aging (NIA) intends to take advantage of a unique opportunity to conduct a proteome-wide analysis in a set of participants with available blood and CSF specimens derived from the same visit. Specifically, this requirement will use CSF and plasma specimens from patients seen in the John Hopkins Neurology service collected by Dr. Abhay Moghekar to examine the relationship between corresponding proteins in blood and CSF, i.e., within the central nervous system. Specifically, the contractor will apply a multiplexed panel of targeted CNS biomarkers to plasma and CSF specimens. Using these data, NIA will identify participants with Alzheimer’s disease, determine disease stage, and quantify the correlation between 7000 proteins measured within and outside the central nervous system. Additionally, NIA will examine how age (young/middle/older age) and disease status (cognitively normal/Alzheimer’s disease) affect the relationship between corresponding proteins measured in CSF and blood.

Period of Performance:

The anticipated period of performance is September 15, 2024 to March 31, 2025

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 the NULISAseq CNS Disease Panel 120 on n=1118 plasma samples (20ul) provided to the contractor by NIA. In addition to providing the NULISA assay, the contractor must perform NGS sequencing to run the assay and provide bioinformatic support.

To perform the assay the contractor must use the NULISA™ Platform, which allows for proteomic analysis with attomolar sensitivity.

GOVERNMENT RESPONSIBILITIES

The government shall provide adequate quantities of archived plasma samples to the contractor to enable the performance of the proteomic assays detailed above.

DELIVERY OR DELIVERABLES

The contractor shall provide an electronic copy of spreadsheet or database files including quantitative measurement of all proteins assayed in the provided plasma samples and relevant quality control metrics (including specimen usage, assay coefficients of variation, assay success/failure rates, normalization process) as well as an electronic copy of a report summarizing the laboratory methods and technical specifications used, both to be delivered within 6 months of receipt of the samples by the contractor.

REPORTING REQUIREMENTS

The contractor shall submit via e-mail as PDF or a MS Word document a progress report 120 days after contract award. The progress report shall include tasks completed and a list of tasks to be completed, inclusive of timeframe. This report shall also describe any problems that arose and state the resolution or provide an explanation if a solution was not identified.

OTHER CONSIDERATIONS

Travel:

N/A

Key Personnel:

A senior researcher is required. The requirements for the senior researcher are as follows:

• A Masters or PhD in a laboratory science field

• Extensive experience in high throughput lab methods.

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. 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:

The contractor is not required to develop, procure, maintain, or use Electronic and Information Technology (EIT) in the performance of the SOW.

Publications and Publicity:

N/A

Confidentiality of Information:

The government will not provide to the contractor any information or data of a personal nature about individual(s) or proprietary information or data pertaining to an institution or organization which is confidential.