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New ultra-sensitive immunoassay platform for blood-based neurodegenerative biomarker detection – Keystone Symposium 2023

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  • May 13, 2023
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Abstract

Neurodegenerative disease markers like neurofilament light protein (NFL) and phosphorylated Tau 181 (p-Tau) can be detected in cerebrospinal fluid (CSF) and are already being used in diagnosis and to guide therapeutic development. However, broad adoption of these tests is hindered by the invasive nature and high cost of CSF sampling. Plasma-based biomarkers are much easier and more cost effective to implement but require significantly higher sensitivity for their reliable detection and have proven challenging for even the most sensitive proteomic technologies today. Here we describe a new proteomic technology, NULISA™ – with ultra-sensitive attomolar level detection.  The NULISA chemistry uses DNA-linked antibodies to convert immunocomplexes to reporter DNA molecules which can be quantified with quantitative real-time PCR (qPCR) or next-generation sequencing (NGS), enabling both ultra-high sensitivity and high multiplexing capacity. The NULISA protocol uniquely employs specially designed background suppression mechanisms to greatly enhance sensitivity and dynamic range.  We have developed NULISA assays for single markers NFL and phosphorylated tau proteins and a 200-plex panel targeting inflammation and immune response-related cytokines and chemokines. We demonstrate the superior performance in limit of detection with NULISA assays compared to existing immunoassays and the ability to generate comprehensive profiles of neuroinflammation in plasma samples. With full automation on the ARGO™ instrument and a wide range of multiplex levels, the ultra-sensitive NULISA technology holds great promise to enable blood-based neurodegenerative biomarkers for the early detection and monitoring of neurodegenerative diseases and aid in the development of new therapeutic approaches

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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.

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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.