NeuroDex ExoSORT ALS Biomarker Breakthrough

NeuroDex, a precision diagnostics company, announced new findings supporting its ExoSORT platform for measuring neuron-derived extracellular vesicle (NDE)-associated TDP-43 as a treatment-responsive biomarker in ALS (ALS). TDP-43 mislocalization is central to over 97% of ALS cases. The ExoSORT platform selectively enriches neuron-derived extracellular vesicles from blood, providing a minimally invasive way to monitor molecular processes in neurons. Findings from multiple independent cohorts demonstrated that NDE-associated TDP-43 distinguished sporadic ALS from healthy controls and increased over time with disease progression. In a Phase 2b clinical trial (PARADIGM) conducted by NeuroSense Therapeutics for its drug candidate PrimeC, NeuroDex's workflow showed a statistically significant reduction in NDE-associated TDP-43 in participants receiving PrimeC, contrasting with increases in the placebo group. This strengthens the evidence linking NDE-associated TDP-43 to ALS disease biology and supports its evaluation as a pharmacodynamic biomarker, potentially improving patient selection and treatment monitoring in clinical trials.