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 ...

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

TAMPA, Fla. — It is a big step forward in Alzheimer’s research as the FDA approves the first blood test to help aid the diagnosis of Alzheimer's Disease. The Lumipulse test (Lumipulse G ...

The FDA reviewed the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio through the 510 (k) premarket notification pathway.

The Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test is designed for the early detection of amyloid plaques associated with Alzheimer’s disease in adults aged 55 years and older who are ...

According to the FDA’s press release, the Lumipulse blood test works by measuring the amount of pTau 217 and beta-amyloid 1-42 in the plasma of the blood.

NEED TO KNOW The FDA greenlit marketing for the first blood test to help diagnose Alzheimer’s disease The test measures two proteins, beta-amyloid and p-tau217, which are hallmarks of the disease ...

While Lumipulse is the first FDA-approved blood test for Alzheimer’s diagnosis, other similar tests are available, but they are not yet authorized by the FDA.

This revolutionary tool, named the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio, marks a shift from traditional, often burdensome testing methods like PET scans and spinal taps to a minimally ...

The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio test, made by the Tokyo-based in-vitro diagnostics company Fujirebio Diagnostics, measures two proteins, pTau217 and β-amyloid 1-42, found in ...