High-Plex NULISAseq™ Inflammation Panel AQ for Comprehensive Profiling of Immune and Inflammatory Biomarkers with Absolute Quantification

Product:
AQ, Immunology, Inflammation
Topic:
Disease Area:
Sample Type:
Topic/Product:
AQ, Immunology, Inflammation
Disease Area:
Sample Type:

Abstract

Highly multiplexed profiling of biomarkers associated with inflammatory, autoimmune and infectious diseases can aid in identification of new diagnostic and therapeutic strategies. Previously, we developed the NULISAseq Inflammation Panel 250-plex assay on the Argo HT platform for relative quantitation of key cytokines, chemokines, and proteins involved in inflammation and immune response.

Absolute quantification (AQ) of analytes in mass concentration units (pg/mL) can be valuable in translational and clinical settings for biomarker validation, disease stratification and monitoring of treatment responses. However, conventional immunoassay quantification involves constructing multi-point calibration curves for each analyte, reducing available wells on the assay plate for samples and adding costs. To address this challenge, we developed a novel approach requiring a single calibrator sample to derive absolute concentrations of samples using a proprietary algorithm.

Here, we report analytical characterization of the Inflammation Panel AQ assay, enabling AQ of 157 analytes simultaneously with minimal sample input and high throughput. Precision and reproducibility assessments demonstrated 5.97% intra-plate and 3.09% inter-plate median CV across 157 AQ targets. With variance component analysis, total median CV was 8.35% across different reagent lots and instruments. Limits of quantification determination demonstrated a wide dynamic range with 9 logs across all targets and upto 6 logs for individual targets. Additionally, >90% of targets showed >50% detectability and >50% quantifiability in a cohort of healthy and diseased plasma (n=119) and serum (n=53) samples.

In summary, the NULISAseq Inflammation Panel AQ provides absolute quantification of >150 analytes to enable discovery of key targets for immunology research.

Authors & Affiliations

Xiao-Jun Ma1, Chan Ho Park1, Alissa O’ Connor1, Tianyang Evan Bai1, Cheng Xie1, Joanne Beer1, Natalia Sherina2, Alexander Van Sant Tsoi2, Dionysis Nikolopoulos2, Niyati Jhaveri1, Dwight Kuo1, Bingqing Zhang1, Yiyuan Yin1, Ioannis Paradis2, Yuling Luo1

1Alamar Biosciences Inc., Fremont, California, USA; 2Karolinska Institute, Stockholm, Sweden

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.