Current treatments for neurodegenerative diseases are limited, and efficacy monitoring in the space, and for other related afflictions, is complex, largely due to the high costs and regulatory challenges in developing and validating effective biomarkers at scale. Inoviv presents a workflow that allows custom mid-plex protein assay generation to address these challenges, modeled via FibroKey and NeuroKey-3. These solutions enable absolute quantification of protein biomarkers through mass spec modalities, ensuring multiplexing while maintaining a high level of specificity using absolute quantification of individual markers. Further, NeuroKey-3, specifically, utilizes immunoprecipitation-based enrichment (IP-MS) in a hybrid assay format. This method ensures high reproducibility, robustness, sensitivity, and an extensive linear dynamic range over six orders of magnitude. We will showcase how these solutions enhance biomarker strategy for disease identification, monitoring, and stratification in support of clinical trial workflows.
Learning Objectives:
Understand the importance of protein biomarkers to support clinical trial workflows
Understand the impact of IP-MS for absolute quantification of low-level biomarkers in neurodegenerative diseases across multiple stages of drug development
Understand the importance of ensuring broad enough coverage of design to appropriately monitor treatment efficacy, while at the same time setting the stage for a successful trial submission
