Development of a Novel Ultrasensitive Multiplex Proteomic Panel for Comprehensive Profiling of Immune and Inflammatory Biomarkers

Topic/Product:
Immunology, Inflammation
Disease Area:
Alzheimer's Disease
Sample Type:
Plasma, Serum

Abstract

Comprehensive profiling of biomarkers linked to inflammatory, autoimmune, and infectious diseases is critical for advancing diagnostic and therapeutic development. Progress in this area has been constrained by the lack of highly sensitive multiplex platforms that can detect across the large dynamic range of protein concentrations. To address this gap, we developed NULISAseq Immune 340 Panel, enabling simultaneous quantification of over 340 proteins involved in inflammation and immunology. The panel provides comprehensive coverage of critical pathways, including apoptosis, immune checkpoints, complement activation, and key disease-associated markers relevant to systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), inflammatory bowel disease (IBD), sepsis, and cancer.

This high multiplex assay was optimized for plasma and serum and underwent extensive analytical characterization to assess precision, reproducibility, detectability, specificity, and dilution linearity. Results demonstrated strong analytical robustness, with median intra- and inter-plate CV below 10%. Over 90% of targets exhibited excellent dilutional linearity (RSQ >0.9) and >90% detectability in plasma and serum samples with high signal-to-noise ratios, while cross-reactivity remained under 1%, confirming high specificity. The novel panel also showed a very high correlation to our existing Inflammation 250 panel for the overlapping targets, representing high analytical robustness and accuracy. These findings underscore the potential of this platform to uncover novel disease mechanisms and enable patient stratification based on molecular profiles.

In summary, the NULISAseq Immune 340 Panel represents significant advancement in immune biomarker analysis, combining breadth, sensitivity, and reproducibility in a single assay. By enabling deep characterization of immune pathways across diverse conditions, it opens new opportunities for early disease detection and longitudinal monitoring in biofluids.

Steve Williams, MD, PhD

CSO

Dr. Willams serves as the company’s Chief Scientific Officer. He was previously Chief Medical Officer at Standard Biotools and at SomaLogic where he pioneered the discipline for discovery and validation of predictive, diagnostic and prognostic models using machine-learning applied to large-plex proteomics. 20 such tests were used for drug characterization, safety and efficacy when incorporated in clinical drug trials at Pharma/Biotech and 17 different multivariate tests were validated and translated into regulated healthcare uses. Prior to SomaLogic, Dr. Williams was at Pfizer in the UK and the USA as a clinical triallist in Translational Medicine, and subsequently as VP, Global Clinical Technology. He sat on the National Advisory Council for the National Institute of Biomedical Imaging and Bioengineering, the Executive Committee for the FNIH Biomarkers Consortium, and worked with FDA and PhRMA on developing evidentiary standards for biomarker qualification. Dr. William’s medical training was in London, at Charing Cross and Westminster Medical School, followed by a PhD in medicine/physiology at the same institution and training in Radiology at the University of Newcastle Upon Tyne. Steve is co-inventor on 26 proteomics patents and author/coauthor on multiple foundational proteomics manuscripts.

Justin McAnear

CFO

Mr. McAnear serves as the company’s Chief Financial Officer. He brings over 25 years of operational and financial leadership experience across various sectors and was instrumental in taking 10x Genomics public in 2019, serving as its CFO for over five years. Mr. McAnear served for over 3 years as Tesla’s VP of Worldwide Finance and Operations, supporting landmark initiatives such as the Model X and Model 3 launches and Solar City acquisition.  He also held various roles at Apple and J&J earlier in his career and served as a naval officer and aviator for over 9 years.