1. FDA has cleared the first blood-based in vitro diagnostic device for detecting amyloid plaques associated with Alzheimer’s disease.
2. The Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio aids in the assessment of Alzheimer’s disease in adults aged 55 years and older presenting with cognitive symptoms.
3. The test quantifies plasma biomarkers and correlates their ratio with cerebral amyloid pathology likelihood.
4. It should not be used as a screening tool or standalone diagnostic, and results should be interpreted within the context of the patient's clinical presentation.
5. The FDA’s decision was supported by a multi-center clinical study evaluating 499 plasma samples from cognitively impaired patients, demonstrating high positive and negative agreement with PET or CSF reference standards.

Source: FDA