SOW..doc

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Proteomics and the brain: A pilot study in CARDIA

Statement of Need and Purpose: Currently most measures of brain health and future risk for dementia are expensive and invasive, so blood-based biomarkers of brain disease are critical. The proteome provides a link between the brain and circulating proteins, which when combined with genetic and other ‘omics’ data can provide important insights into the mechanisms related to dementia, and predictive plasma-based signatures of future risk for dementia [1].

1. Yurkovich JT, Hood L. Blood Is a Window into Health and Disease. Clin Chem. 2019 Jun 6. pii: clinchem.2018.299065. doi: 10.1373/clinchem.2018.299065.

Background Information and Objective: Understanding the brain remains one of the 21st century’s greatest challenge. There has been some progress in identifying genes that regulate the normal development of the brain, as well as the abnormal development of pathology that effects a wide range of system dysfunction. As a part of this effort, it is now possible to investigate, on a voxel by voxel, basis the relationship of various measures of brain structure and function measured on MRI to ‘omics’ measures including genomics, transcriptomics, epigenetics, metabolomics, proteomics and microbiomics. The Coronary Artery Risk Development in Young Adults (CARDIA) cohort has already been well characterized with genomics, the microbiome, and metabolomics. The addition of data on the proteome will enhance the value of this cohort in the broad objective of identifying risk factors for, mechanisms underlying, and clinical risk scores predicting, disease.

For an initial study, we propose selecting proteins with special emphasis on Organ Damage, Oncology, and Development (Product codes 91703, 91402, 91901), to test hypotheses related to putative mechanisms regulating organ development and damage of tissue, in our case, brain tissue. This initial set of analysis will be performed on 300 CARDIA participants who have MRI measures in the 25th and 30th year of cohort follow-up.

The overall program objective of this requirement is to obtain assay results for 92 proteins/panel in 3 panels focusing on organ development, development, and oncology. These proteins will be assayed using real-time PCR, that allows for scalable multiplex immunoassay [PEA technology]. A limiting factor of multiplexed immunoassays is the amount of plasma needed and the antibody cross-reactivity, which restricts the degree of multiplexing of most assays to below 10-plex. The PEA technology is unique in the low amount of bio-sample needed and the increase in specificity that results from the unique oligonucleotide antibody-pairs that contain unique DNA sequences allowing hybridization only to each other. Cross-reactive events will not be detected with Olink’s panels since only matched DNA reporter pairs are amplified with real-time PCR. This allows for scalable multiplexing without loss of specificity and sensitivity.

Period of Performance:

12 months

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:

Plasma samples for 300 individuals will be plated into 96 well plates, 3 plates with 80 unique ids, and one with 60 unique ids randomly selected. Each well will have 20 ug of plasma. Leftover samples will be taken care of pending decisions at the end of the project and could include storing, returning to archive, or destroying.

LEVEL OF EFFORT:

The analysis of the 300 bio-samples for protein levels within one year.

GOVERNMENT RESPONSIBILITIES

The government will provide the 300 bio-samples needed in the required 96-well plate layout for the protein assay following the required placement of the samples per plate.

DELIVERY OR DELIVERABLES

Requirement is on a per sample/per panel completed assay. The contractor should apply the PEA technology to detect proteins from 3 pre-specified panels of 96 proteins, focusing on organ damage, development and oncology. The contractor will deliver excel files with CARDIA ID, and protein level values and a report on the quality of the data. These files will be delivered within 3 months of receipt of the samples.

REPORTING REQUIREMENTS

The final report should include quality measure of each measured protein level, overall non-detection rate, coefficient of variation of the measures, batch effects, any data needed for future standardization and pooling with other data, normalization procedures.

OTHER CONSIDERATIONS

Data Rights:

The National Institute on Aging shall have unlimited rights to and ownership of all deliverables provided under this procurement including reports, analyses, recommendations 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,” shall be incorporated into any resulting award by reference.

Section 508—Electronic and Information Technology Standards:

The contractor is compliant with Federal Government Electronic and Information and Technology Standards.

Confidentiality of Information:

All data are de-identified and cannot be traced back to an individual. The contractor has no access to the link between an individual and their data. This is kept in a secure environment at the CARDIA Coordinating center Version 11-30-2016-1

FAR Part 11—Describing Agency Needs