NEW YORK ─ Fujirebio Diagnostics on Wednesday announced it has applied to the US Food and Drug Administration for clearance for its Lumipulse G β-Amyloid Ratio (1-42/1-40) diagnostic test.
The firm said it anticipates that the test, if cleared, would be among the first commercially available in vitro diagnostic assays in the US to help in the assessment of Alzheimer’s disease.
The test runs on the firm's fully automated Lumipulse G1200 instrument.