The FDA cleared Fujirebio Diagnostics’ Lumipulse plasma pTau217/β‑amyloid 1‑42 ratio test for detecting amyloid pathology in adults aged 50 and older with cognitive impairment, marking the first blood‑based in vitro diagnostic authorized for Alzheimer’s disease pathology. The assay runs on the Lumipulse G1200 analyzer and demonstrated performance comparable to PET and CSF biomarkers in validation studies. The clearance provides clinicians a minimally invasive tool to identify patients with amyloid pathology and could broaden access to biomarker‑guided diagnosis and therapeutic decision‑making. The test is likely to affect clinical workflows, trial enrollment and drug‑development strategies by easing screening for anti‑amyloid therapies and enabling larger population‑scale biomarker assessment in routine practice.