Biomarker Discovery and Validation
In the quest for discovering novel biomarkers suitable for the early and reliable diagnosis of HIE, InfanDx focuses on blood-born metabolites. In our biomarker discovery we combined a hypothesis-driven approach using candidate metabolites from pathway analysis and literature with an unbiased large-scale metabolomics discovery using LC-MS technology. Based on this approach, we have identified several candidate biomarkers and biomarker panels that are now further evaluated in dedicated prospectively collected clinical cohorts with several years of follow-up, namely
The final biomarker panel is expected to be defined in Q3-2021, the validation to be completed in Q2-2022.
To establish a reference method for further research, we are in the process of developing a targeted Generation 1 LC-MS Method that will be optimized for the final biomarker panel. It will serve as gold standard for the development of further assays for the clinical routine as well as providing a template for Laboratory-Developed Tests (LDT) to be implemented for early-adopter use at key academic medical centers in Europe and the US from mid-2022 onwards.