Rapid Comprehensive Diagnostic Test for Multi-System Autoimmune Disease

The contract seeks the development of a rapid, comprehensive diagnostic test for multi-system autoimmune disease, aiming to address a significant unmet need in healthcare by enabling primary care physicians to identify and predict tissue-specific autoimmune manifestations early and accurately. Leveraging recent advances in detecting circulating immune signatures and tissue-specific molecular markers, the desired diagnostic tool must be sufficiently sensitive and specific to support timely clinical decisions and streamline referrals to specialists without requiring complex laboratory infrastructure. The goal is to transform diagnostic workflows by shifting detection from reactive, symptom-driven approaches to proactive, biomarker-based identification of autoimmune activity across multiple organ systems. This solicitation, issued under ARPA-H 06 by the Department of Health and Human Services, is a Total Small Business Set-Aside under the SBIR/STTR mandate, restricted to businesses with fewer than 500 employees, and falls under NAICS code 325413 for medical and diagnostic laboratory services. Proposals are due by September 30, 2027, and the technology must be scalable, clinically viable, and capable of integration into general medical practice. The initiative emphasizes innovation in diagnostic biomarker detection and aims to deliver a point-of-care or near-point-of-care solution that enhances early intervention, reduces diagnostic delays, and improves patient outcomes across the autoimmune disease spectrum.