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Statement of Work Proteomic Profiling of individuals of African Descent with metabolic disorders

Background:

The National Institutes of Health (NIH) mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. The National Human Genome Research Institute (NHGRI), mission has expanded to encompass a broad range of studies aimed at understanding the structure and function of the human genome and its role in health and disease. A critical part of the NHGRI mission continues to be the study of the ethical, legal and social implications (ELSI) of genome research. The Center for Research on Genomics and Global health (CRGGH) investigates the potential role of genetic and environment factors in the development of complex diseases such as Type 2 diabetes, obesity and hypertension. For more than 20 years, GRGGH has invested in collecting phenotypic data in almost ~6000 + individuals of African descent both in the United States of America and in Africa to close the gap in genetic study inequity (given that the majority of genetic studies to-date has been conducted in population of European ancestry) across populations and to understand health disparity among minority populations.

CRGGH investigators use number of analytical tools to understand the pathophysiology of metabolic disorders. Throughout the years, CRGGH investigators have systematically accumulated different type of -omics data (genomics, transcriptomics, microbiomes) on all or some of our participants with the objective of using integrated analyses to decipher the etiology of metabolic disorders.

Purpose and Objectives:

The purpose of the procurement is to concomitantly evaluate multiples proteins (~3,000 biomarkers) i.e., proteomics in plasma samples of diabetic and non-diabetic individuals of African descent recruited through CRGGH’s flagship cohort, the AADM study. The Center for Research on Genomics and Global Health (CRGGH) investigates the potential role of genetic and environment factors in the development of complex diseases such as Type 2 diabetes, obesity and hypertension.

With foresight towards integrating multi-omics panels (genomics, transcriptomics, metabolomics, epigenomics) in our analyses to comprehensively decipher the pathophysiology of metabolic disorders and related disorders in underserved and under-represented populations in medical research. Interestingly, these populations have a high burden of metabolic disorders, but remain the least studied. The comprehensive scope of proteomic data required for these analyses includes targeted and specific pathways e.g., inflammation which has been associated with number of metabolic disorders.

Procurement:

This procurement is to provide the following:

Olink® Explore 384 Inflammation (Product Code 91101), Olink® Explore 384 Oncology (Product Code 91102), Olink® Explore 384 Cardiometabolic (Product Code 91103), Olink® Explore 384 Neurology (Product Code 91104), Olink® Explore 384 Inflammation II (Product Code 91105), Olink® Explore 384 Oncology II (Product Code 91106), Olink® Explore 384 Cardiometabolic II (Product Code 91107), Olink® Explore 384 Neurology II (Product Code 91108).

Period of Performance:

Upon award for 12-Months

Contractor’s Requirement and Deliverables:

The Government’s minimum requirements are as follows:

· The Contractor shall provide an effective tracking of the samples throughout the process (from sample receipt to sample return).

· The Contract shall present sufficient capacity to measure 3020 proteins/biomarkers in 200 plasma samples.

· The Contractor shall provide a comprehensive data output.

· The Contractor shall destroy all samples 6 months after project completion unless specifically instructed otherwise.

· The Contractor shall provide documentation of the process of generating the proteomic data including internal reference controls and subsample replicates of samples provided as well as the raw data generated.

· The Contractor shall provide regular reports and ad hoc conference call updates throughout the process from the receipt of samples to the final deliverables.

Deliverables:

The Contractor shall deliver the following:

· The Contractor shall a Certificate of Analysis (a summary report);

· The Contractor shall provide data from the analyzed protein biomarkers presented in Normalized Protein eXpression (NPX) units;

· The Contractor shall provide deliverables to NHGRI via a secure cloud-based service located eu.mydata.olink.com for services performed in Boston. The Government will receive login credentials and information about the cloud-based service, the Government must have an account (“MyData account”) in order to receive the Deliverables.

· The Contractor shall provide login credentials to additional, the Government upon receipt of signed, written request.

Other: The deliverables are provided to the Government, and the services are deemed completed when Olink has uploaded the deliverables to the Government MyData account and has provided written notice to the Government contact person set forth above.

Government Responsibilities:

· The Government shall review written progress report.

· The Government shall participate in monthly phone calls for updates.

· The Government shall review and approve all invoices.

· The Government shall inspect and approve all samples before acceptance.

Contract Type:

The contract type for this requirement is firm-fixed price.

Place of Performance:

The contractor will perform all services on site at vendor’s facility in Sweden and Boston.