Transforming autoimmune diagnostic and disease monitoring with a scalable IP-to-MS platform for autoantigen profiling

The National Institute of Allergy and Infectious Diseases awarded Impact Proteomics LLC $320,863 on August 1, 2026, under the Allergy and Infectious Diseases Research program (CFDA 93.855) to establish clinical and technical feasibility of an immunoproteomics diagnostic platform for autoimmune disease detection and monitoring.

Impact Proteomics will develop and validate an IP-to-mass spectrometry (IP-to-MS) workflow that leverages a patented PromTag system to separate autoantigens from immunoglobulin contaminants, enabling rapid detection of both known and novel autoantibodies from minimal serum volume (as little as 10 microliters). The Phase I project targets systemic sclerosis diagnosis and includes two primary aims: establishing detection limits, signal thresholds, and quantitative ranges for key SSC biomarkers including topoisomerase I and RNA polymerase III; and applying IP-to-MS analysis to a 1,000-sample cohort of annotated SSC patient samples to benchmark autoantibody profiles, stratify disease subtypes, and develop predictive machine learning models.

The award is structured as an SBIR Phase I grant, a classification reflecting the program's emphasis on technological innovation and commercial potential. The period of performance runs from August 1, 2026, through July 31, 2027, with work performed in Pittsburgh, Pennsylvania. The platform addresses a public health need in autoimmune diagnosis, where current labor-intensive assays produce false positives and missed diagnoses, particularly in atypical presentations.

Abstract

Autoimmune diseases, such as systemic sclerosis (SSC), pose a growing public health challenge, affecting 7-9% of the U.S. Population, impacting 23-30 million individuals. Accurate and timely diagnosis remains a major barrier to effective treatment, as current clinical tests like immunoprecipitation (IP), enzyme-linked immunosorbent assay (elisa), and double-immunodiffusion (did) are labor-intensive, low-throughput, and biased toward known autoantibodies. These limitations often result in false positives, missed diagnoses, and delayed care, particularly for patients whose conditions do not fit textbook presentations. The need for a more comprehensive, scalable, and unbiased diagnostic tool is critical to improving outcomes for patients with autoimmune diseases. Impact proteomics has developed a novel immunoproteomics platform, IP-to-mass spectrometry (IP-to-MS), which leverages a patented promtag system (patent: US-11655271-B2) to separate autoantigens from abundant contaminants like immunoglobulins. This workflow enables rapid, reproducible, and quantitative detection of both known and novel autoantibodies from as little as 10 ÌL of patient serum. Unlike conventional assays, IP-to-MS provides high-resolution autoantibody profiles that can guide diagnosis, monitor disease progression, and stratify patients for personalized treatment. This phase i sbir project will establish the clinical and technical feasibility of IP-to-MS for autoimmune diagnostics. Aim 1 will define detection limits, signal thresholds, and quantitative ranges for key SSC biomarkers, such as topoisomerase i and RNA polymerase III. Aim 2 will apply IP-to-MS to a well-annotated cohort of 1,000 SSC patient samples to benchmark autoantibody profiles, stratify disease subtypes, and explore predictive machine learning models. By enabling more accurate, rapid, and comprehensive autoimmune testing, this project supports public health by improving diagnostic access, reducing healthcare disparities, and enhancing precision medicine for immune-mediated diseases. Success will position IP-to-MS for clinical adoption and further development toward FDA clerance in phase II.