Qualification of the S-PLEX Neurology Panel 1 (GFAP, NfL & Tau) MSD Assay​ ​– NBC 2025

Purpose

Neurofilament Light chain (NfL), glial fibrillary acidic protein (GFAP), and Tau have been identified as valuable diagnostic and prognostic biomarkers of brain injury and other neurological disorders. In the context of a clinical trial, data from such measurements may play a critical role in informing treatment efficacy and safety evaluations, patient enrollments as well as stratification. Assays which evaluate these analytes in plasma and CSF can be used to measure changes in each matrix in response to treatment. Ultimately, this data can be used to support assessment of the biomarkers in plasma, which is a much less invasive sample to collect compared to CSF, in later phase clinical trials. Leveraging multiplexed panels for these biomarkers enables multiple analytes to be measured simultaneously from a single sample, which is especially advantageous for testing rare or volume limited samples. Platforms such as MSD offer a wide dynamic quantitation range and sensitivity with the added benefit of low sample volumes unlike conventional platforms such as ELISA.