FDA Approves First-Ever Blood Test for Alzheimer’s Diagnosis

Fda Approves First Ever Blood Test For Alzheimer’s Diagnosis

Hold on to your lab coats — the FDA just greenlit the first-ever blood test to help diagnose Alzheimer’s. Yes, a simple blood draw. No brain scans. No spinal taps. No drama.

The test, called Lumipulse, sounds more like a sci-fi gadget than a medical breakthrough — and honestly, it kinda is.

Developed by Fujirebio Diagnostics, the test measures two key proteins in your blood: pTau217 and beta-amyloid 1-42. Why those two? Because when their levels are off, it usually means amyloid plaques — aka the messy brain gunk linked to Alzheimer’s — are likely building up.

The FDA said the test is designed for adults over 55 showing signs of cognitive decline. Think forgetfulness, confusion, or suddenly putting your keys in the fridge.

And get this — it’s surprisingly accurate. In clinical trials with nearly 500 patients, the test got it right about 92% of the time when compared to PET scans or spinal fluid analysis. Even better? It correctly ruled out Alzheimer’s in 97% of cases. That’s some serious diagnostic swagger.

Reuters reports that the FDA approval comes just as treatments like Leqembi and Kisunla are hitting the market — drugs that only work if Alzheimer’s is confirmed. So this test? It’s about to become the golden ticket to getting on the right meds faster.

But before we all go running to get pricked — a reality check. The FDA says this is not a standalone tool. You still need a full workup: doctor visits, cognitive assessments, and a deep dive into your medical history.

Still, a quick blood test beats getting a radioactive brain scan or a needle in your spine. And that, folks, is a win.