Optina Cerebral Amyloid Status (CAS) has earned FDA breakthrough designation, addressing critical Alzheimer's diagnostic needs. CAS is an objective and accurate diagnostic tool designed to assess cognitive health in individuals with Mild Cognitive Impairment (MCI). This shift toward biomarker-based testing in cognitive health is driven by new guidelines set to take effect in late 2023 and the recent coverage by CMS (Centers for Medicare & Medicaid Services) for disease-modifying drugs."