Statement of Work.pdf

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

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

Autoantibody Immunoproteomics and Aging

Statement of Need and Purpose:

To perform multiplex antibody assays using a high-throughput immunoproteomics approach to assess subclinical and preclinical autoimmune diseases and investigate their association with aging and age-related diseases in a prospective cohort

Background Information and Objective:

Autoimmune diseases are a group of more than 80 chronic illnesses due in part to an inappropriate immune system response that leads the body to attack itself. More than 23.5 million people in the US are affected by autoimmune diseases. For some unknown reason, many of these diseases are increasing in prevalence in industrialized countries in the past few decades. Since most of these autoimmune diseases do not have cures, patients often bear a lifetime of illness. In addition to the debilitating symptoms and large medical expenses, autoimmune diseases disproportionately affect women. Therefore, it is important to predict and prepare for the changing landscape of health outcomes that are associated with these conditions. Several autoimmune conditions have been linked to age-related diseases, including cancer and dementia. The underlying mechanism for this association is not fully known, but common genetic predisposition and chronic inflammation have been proposed.

Circulating autoantibodies can serve as biomarkers for early diagnoses and provide opportunities for therapeutic interventions. Since autoantibodies may be detected in asymptomatic individuals even decades before the clinical symptom emerges, many studies have evaluated the predictability of autoantibodies to the eventual development of overt clinical autoimmune disease. Only a paucity of data exists in using autoimmune disease-associated autoantibodies to predict cancer risk or other age-related conditions.

Multiplex technologies such as protein microarrays enable the exploration of the intricacy of the immune system not only as a single measure but also of relationships between the biomarkers.

Many autoimmune diseases do not have a single autoantibody for the clinical diagnoses, and studies have shown that a combination of multiple markers may give the best discrimination.

Furthermore, autoimmune diseases often are a constellation of various autoimmune conditions co-occurring within the individual. Our aim is to construct autoantibody multiplex profiles using immunoproteomics to identify autoantibodies and investigate their association with prospective autoimmune diseases and other age-related diseases.

Period of Performance:

Four years from the date of the award.

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:

The contractor will construct and perform antibody array testing using a high-throughput immunoproteomics approach for ~1,700 proteins targeting selected autoantigens and 16,000 blood samples. The contractor should be able to construct and perform antibody assays for tens of thousands of antigens in hundreds of samples AND for hundreds of antigens in tens of thousands of samples. The contractor should support data analysis and interpretation. The contractor needs to be proficient in high-throughput multiplex assays for disease-associated antibodies, as demonstrated by peer-reviewed publications, meeting presentations, and/or other scientific reports.

Specific requirements for the assay platforms are as follows.

• Well-folded and often functional protein antigens, including conformational epitopes

• Use of freshly produced full-length antigens

• Easy data interpretation of target antigens of disease-associated antibodies

• Flexible and expedient adjustment of antigen contents

• Flexible with producing antigens using different expression systems

• Capable of assaying both human and microbial antigens simultaneously

• High-yield protein features with high sensitivity

• Quantitatively reproducible

• Compatible with the adaptive experimental design. Target antigens and the number and type of samples are subject to change as data are generated

LEVEL OF EFFORT:

Laboratory analysis

GOVERNMENT RESPONSIBILITIES

The government will obtain and ship the samples, select markers to be included in the immunoproteomics array, and communicate with the contractors on the process of laboratory testing. The contract will not require access to any government facilities.

DELIVERY OR DELIVERABLES

Electronic data files with immunoproteomics test results for submitted samples within 48 months from the date of the award.

REPORTING REQUIREMENTS

The contractor should report any problems encountered and progress on the resolution.

OTHER CONSIDERATIONS

Travel:

Contract travel is not required.

Key Personnel:

Information System Security Plan:

No personal identifications will be accessed by the contractor

Data Rights:

The government has the sole right regarding the use, production, and disclosure of the data generated.

Section 508—Electronic and Information Technology Standards:

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

Publications and Publicity:

The contractor may participate as a co-author of the articles to be published as a result of the requirements of the SOW.

Confidentiality of Information:

No personal identifications will be accessed by the contractor. The data will be delivered via the NIH Box.