Attachment-SOW Protein analysis in cerebrospinal fluid samples (CSF).pdf

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

Statement of Work (SERVICES) SOW

GENERAL INFORMATION

Title of Project:

Protein analysis in cerebrospinal fluid samples (CSF)

Statement of Need and Purpose:

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 misfolded 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.

Anticipated Period of Performance:

Base Period: August 1, 2024 thru October 31, 2024 (QTY of Samples = 1,200) Optional Period 1: November 1, 2024 thru December 31, 2024 (QTY of samples = 200) Optional Period 2: January 1, 2025 thru February 28, 2025 (QTY of samples = 200) Optional Period 3: March 1, 2025 thru April 30, 2025 (QTY of samples = 200) Optional Period 4: May 1, 2025 thru June 30, 2025 (QTY of samples = 200) Optional Period 5: July 1, 2025 thru August 31, 2025 (QTY of samples = 200) Optional Period 6: September 1, 2025 thru October 31, 2025 (QTY of samples = 200) Optional Period 7: November 1, 2025 thru December 31, 2025 (QTY of samples = 200) Optional Period 8: January 1, 2026 thru February 28, 2026 (QTY of samples = 200)

Optional Period 9: March 1, 2026 thru April 30, 2026 (QTY of samples = 200) Optional Period 10: May 1, 2026 thru June 30, 2026 (QTY of samples = 200) Optional Period 11: July 1, 2026 thru August 31, 2026 (QTY of samples = 200) Optional Period 12: September 1, 2026 thru October 31, 2026 (QTY of samples = 200) Optional Period 13: November 1, 2026 thru December 31, 2026 (QTY of samples = 200) Optional Period 14: January 1, 2027 thru February 28, 2027 (QTY of samples = 200) Optional Period 15: March 1, 2027 thru April 30, 2027 (QTY of samples = 200) Optional Period 16: May 1, 2027 thru June 30, 2027 (QTY of samples = 200) Optional Period 17: July 1, 2027 thru August 31, 2027 (QTY of samples = 200) Optional Period 18: September 1, 2027 thru October 31, 2027 (QTY of samples = 200) Optional Period 19: November 1, 2021 thru December 31, 2027 (QTY of samples = 200) Optional Period 20: January 1, 2028 thru February 28, 2028 (QTY of samples = 200) Optional Period 21: March 1, 2028 thru April 30, 2028 (QTY of samples = 200) Optional Period 22: May 1, 2028 thru June 30, 2028 (QTY of samples = 200) Optional Period 23: July 1, 2028 thru August 31, 2028 (QTY of samples = 200) Optional Period 24: September 1, 2028 thru September 30, 2028 (QTY of samples = 200)

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 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

Vendor staff will provide the assay results via reporting transfer thru email.

GOVERNMENT RESPONSIBILITIES

Government will provide 6,150 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