INTRODUCTIONParkinson’s disease (PD) remains largely a clinical diagnosis based on characteristic motor features and supportive clinical criteria. However, widespread clinical implementation requires a deeper understanding of how biomarker results should be interpreted across diverse patient populations. As for any in vitro diagnostic test, compliance with relevant regulatory standards is required for the use of αSyn-SAA as part of medical decision-making. In addition to scientific and regulatory considerations, clinical implementation is influenced by intellectual property and licensing frameworks. Nevertheless, widespread clinical implementation requires a deeper understanding of biomarker interpretation across the disease continuum.