Quest Diagnostics (NYSE: DGX), a leader in diagnostic information services, including advanced diagnostics for brain health, today announced it plans to offer laboratory testing based on the ...

The FDA label update boosts GE HealthCare’s Vizamyl to a market advantage despite the emergence of blood-based tests.

After decades of research, the U.S. Food and Drug Administration (FDA) has approved a test that can detect the buildup of amyloid plaques in the brain—a key marker of Alzheimer’s disease, ...

The FDA has approved the first blood test for Alzheimer's disease based on a blood test – from Fujirebio – in a step forward for early diagnosis. The test, dubbed the Lumipulse G pTau217/ß ...

This initiative follows the landmark FDA clearance of the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio test developed by Fujirebio Diagnostics in May 2025.

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 ...

The US FDA has authorised a new test that can detect amyloid plaques in early-stage Alzheimer's disease without the use of PET scans, which expose patients to radiation. Fujirebio Diagnostics ...

Lumipulse G is not the only Alzheimer’s blood test available, but it’s the first to be introduced since the FDA increased oversight on lab tests. FDA approved Lumipulse G only for patients ...

More The U.S. Food and Drug Administration (FDA) recently cleared a blood test that detects signs of Alzheimer's disease in the brain, according to multiple studies.

In May, the U.S. Food and Drug Administration (FDA) cleared the first-ever blood test to detect Alzheimer’s, announcing its approval of the first in-vitro diagnostic device, Lumipulse.

Biotech FDA aims for 'rapid or instant' drug reviews, with AI tool initially assessing applications By Darren Incorvaia Jun 11, 2025 12:45pm ...