FDA approves first blood test from Fujirebio for diagnosing Alzheimer's

dancsfo

https://www.statnews.com/2025/05/16/alzheimers-fujirebio-fda-approval/

This can be less expensive than PET scans or less invasive than examining spinal fluid

Marp

https://www.fda.gov/news-events/press-announcements/fda-clears-first-blood-test-used-diagnosing-alzheimers-disease#:~:text=The%20Lumipulse%20G%20pTau217%2F%C3%9F,and%20symptoms%20of%20the%20disease.

Original link seems to be behind a paywall so here's another one about this test.

It's interesting to note that a false positive test could result in unnecessary treatment for Alzheimer's disease and a delay in obtaining a correct diagnosis. How often does the opposite occur today where a patient is diagnosis of having something else and receives unnecessary treatment for that, delaying treatment for their Alzheimer's?

dancsfo

https://alzconnected.org/discussion/comment/243983#Comment_243983

Sorry for including a paywall link.

In regards to false positives, this article provides some pros and cons. The good point from this article is:

"Neurologists are unlikely to use these tests, which will be used by primary care physicians. If you do get a positive result from a blood tau or amyloid test, please be evaluated by a neurologist to determine if they have any clinical significance.”

So I think this is what happens today, when a primary care physician may provide a Mini-Cog test, and if dementia is suspected, there is a referral to a neurologist. With regards to delaying treatment. of Alzheimer's due to being diagnosed for something else, I think running multiple tests can help (let's say a positive Fujireobo's Lumipulse in addition to a positive from whatever was used for the other diagnosis, if there are symptoms or early concerns, then I think the same thing can happen: Multiple referrals for further evaluation.

https://www.medicalnewstoday.com/articles/first-blood-test-alzheimers-gets-fda-greenlight-3-things-to-know#Will-this-aid-early-diagnosis-for-Alzheimer-s-disease

A statement from the Alzheimer's Association is here.

https://www.alz.org/news/2025/fda-clears-blood-test-alzheimers-diagnosis