75N95025R00048.SOW.pdf

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

STATEMENT OF WORK

GENERAL INFORMATION

Title of Project:

Proteomic Analysis Services

Statement of Need and Purpose:

Biomarkers play a critical role in understanding, diagnosing, and monitoring disease progression and therapeutic efficacy. This requirement for NULISA testing aims to identify biomarkers which will provide information about underlying molecular changes associated with Alzheimer’s

Disease and Related Dementias in well characterized samples from patients..

Background Information and Objective:

The NIH Intramural Center for Alzheimer’s Disease and Related Dementias is an interdisciplinary initiative that is dedicated to advancing our understanding and treatment of

Alzheimer’s disease and related dementias (AD/ADRD). Biomarkers play a critical role in understanding, diagnosing, and monitoring disease progression and therapeutic efficacy. We aim to identify biomarkers which will provide information about underlying molecular changes associated with AD/ADRD in well characterized samples from patients.

Period of Performance:

Base Year: September 15, 2025 thru September 14, 2026

Option Year 1: September 15, 2026 thru September 14, 2027

Option Year 2: September 15, 2027 thru September 14, 2028

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:

NULISA PLATFORM: Vendor shall provide NuLISA CNS panel proteomic analysis per the specifications below:

• Vendor shall analyze cohorts independently, but all within the same batch of reagents to ensure consistency.

• Vendor shall run pooled Government samples with known analytes on each plate for normalization during quantification of proteins and library preparation.

• Vendor shall include a NuLISA (QC) bridging cohort to assess analytical performance over time and normalize datasets.

• Vendor’s QC bridging cohort (n=30) shall be matched to the biofluid of interest—whether cerebrospinal fluid (CSF) or EDTA plasma.

• Vendor’s QC bridging cohort shall be used over multiple Government sample cohorts to ensure data set harmonization among cohorts.

• Vendor’s QC bridging cohort shall control for changes in lots and between cohorts for batch correction.

• Vendor’s quality control measures shall include a NuLISA plate for external controls, and internal vendor controls to control for individual plate variance.

• Vendor shall have the throughput capacity to prepare NuLISA libraries for up to 2,400 samples per week.

• Vendor shall perform whole-genome sequencing of libraries using Illumina NovaSeq

2000 platform, utilizing 150 bp paired-end sequencing

• Vendor shall perform raw sequencing data in FASTQ format via secure cloud server within two weeks of receiving the prepared libraries

• Vendor shall perform quality control checks on the data and communicate final results to the Government within an additional two weeks, provided all QC benchmarks are met.

SEED AMPLIFICATION ASSAY (SAA): Vendor shall perform proteomic analysis using the

Amprion platform.

• Vendor’s reagents shall be tested and verified prior to running the SAA. They will be assessed across a set of standards with positive and negative controls.

• Vendor’s run lengths shall be run long enough to obtain data for Alzheimer’s Disease, Multiple System Atrophy, Parkinson’s Disease and Dementia with Lewy Bodies.

• Vendor’s SAA data shall be reported so that kinetic information is included, as well as positivity and negativity.

• Vendor shall run samples with enough replicates to eliminate ambiguity with the majority of samples.

• Vendor shall demonstrate proficiency with CSF and plasma samples from subjects with neurodegenerative disease and provide evidence of successful data analysis among several diseases and cohorts.

LEVEL OF EFFORT:

Vendor shall perform quality control checks on the data and communicate final results to the

Government

GOVERNMENT RESPONSIBILITIES

The Government will provide CSF or plasma samples as starting material to the vendor.

DELIVERY OR DELIVERABLES

CSV files denoting log2 values of cohort samples

CSV files of data QC

PDF for project report and QC summary

REPORTING REQUIREMENTS

Vendor staff shall provide biomarker readouts by CSV files denoting log2 values of each biomarker. A separate files (CSV and PDF) shall provide and describe the results from the bridging samples and study QC. Files shall be reported password projects files via email, and communication regarding results shall be conducted via email

OTHER CONSIDERATIONS

Travel:

The principal place of performance is the vendor’s work site. Travel for vendor employees will not be necessary.

Key Personnel:

Vendor will provide a dedicated project manager to the government as a point of contact for the services.