The Scientist

Fujirebio Receives Marketing Clearance for Lumipulse® G pTau 217/ β-Amyloid 1-42 Plasma Ratio In-Vitro Diagnostic Test

Fujirebio today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) ...
Medical Xpress

FDA OKs marketing of new test to help diagnose Alzheimer's disease

The U.S. Food and Drug Administration granted marketing approval for the Lumipulse G β-Amyloid Ratio (1-42/1-40) test, the first in vitro diagnostic test for early detection of amyloid plaques ...
Monthly Prescribing Reference

FDA Greenlights In Vitro Diagnostic Test to Assess for Alzheimer Disease

Credit: Getty Images. The Lumipulse G β-Amyloid Ratio (1-42/1-40) test is intended to be used as an aid in adults 55 years of age and older presenting with cognitive impairment who are being evaluated ...
Fox Business

FDA approves marketing for new Alzheimer's early detection test

The Food and Drug Administration has approved marketing for the first in vitro diagnostic test for early detection of Alzheimer’s disease. FDA PUTS NEW LIMITS ON JOHNSON & JOHNSON VACCINE DUE TO RARE ...