The FDA has cleared the first blood-based in vitro diagnostic device, the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio, designed to aid in detecting amyloid plaques associated with Alzheimer's disease in adults aged 55 years and older presenting with cognitive symptoms. The test quantifies plasma biomarkers and correlates their ratio with the likelihood of cerebral amyloid pathology. The test is supported by a multi-center clinical study showing high positive and negative agreement with PET or CSF reference standards, and it may reduce reliance on PET imaging or CSF testing. However, 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.

Source: FDA