SBIR/STTR Research Award

DIAGNOSTIC TEST FOR CHRONIC FATIGUE AND FIBROMYALGIA

Award identifier 4c0e2a7009d60f8e741e6127f8d6ee38e2837e34319da8d52154c38042a5439fAwarding agency Department of Health and Human Services

Award amount

$65,690

Program and phase

SBIR · Phase I

Award year

1997

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Award details

Awarding agency
Department of Health and Human Services
Branch
Not reported
Recipient company
AUTOIMMUNE TECHNOLOGIES, LLC
Proposal award date
Not reported
Contract end date
Not reported
UEI
NBLGCCAQXG85
Solicitation number
Not reported
Topic code
Not reported

Research abstract

The long-term goal is to demonstrate that the Anti-Polymer Antibody Assay is diagnostic for chronic fatigue syndrome patients and fibromyalgia patients. In a pilot study 55 % (6/11) of chronic fatigue syndrome patient sera, 71 % (12/17) of fibromyalgia patient sera and 9 % (1/11) sera from healthy normals were seroreactive on the Anti-Polymer Antibody Assay. Therefore, it is hypothesized that the Anti-Polymer Antibody Assay is diagnostic for chronic fatigue syndrome patients and fibromyalgia patients. The purpose of this proposal is to establish the ability of the assay to identify chronic fatigue patient sera and fibromyalgia patient sera in a retrospective multi-center blinded trial. The data generated from the multi-center trial will be used as the basis for the submission of a prospective Phase II multicenter trial. In addition, data from the Phase I trial will be used in the application to the Food and Drug Administration for approval of the Anti-Polymer Antibody Assay as a diagnostic test for chronic fatigue syndrome and fibromyalgia.

Technology keywords

Not reported

Other awards by this recipient

Verified by the same UEI. These are other public SBIR/STTR award pages, not a merged company record.

Research funding history

7 SBIR/STTR records share this UEI (1997–2018). Reported award amounts total $5,476,764. Reported amounts are not federal obligations.

Phases: Phase I, Phase II

Agencies: Department of Health and Human Services

Agency intelligence

Department of Health and Human Services

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