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The FDA clears the first blood test for diagnosing Alzheimer's disease

16 May 2025 at 20:12

There's a new way to screen for early detection of Alzheimer's disease. On Friday, the Food and Drug Administration (FDA) cleared the first blood test for the disorder. Fujirebio Diagnostics' Lumipulse measures the ratio of two proteins that correlate with the presence or absence of Alzheimer's. Previously, patients being screened for Alzheimer's were limited to more invasive options: a PET Scan or spinal tap.

Lumipulse is intended for use in clinical settings with patients exhibiting signs of cognitive decline. At least in its current form, it isn't something the general population can ask for as a standard screening.

The test works by measuring two proteins: pTau217 and ฮฒ-amyloid 1-42. The blood test calculates their ratio, which correlates with the buildup of amyloid plaques in the brain. People with Alzheimer's have elevated pTau217 and lower ฮฒ-amyloid 1-42.

In a clinical study, the test performed better with negative results than positive ones. As such, Reuters reports that the test will likely be used initially to rule out Alzheimer's. Over 97 percent of negative results corresponded with a negative PET scan or CSF test result. Results for positives were a bit lower: a 91.7 percent correlation. So, positive results will need to be confirmed with more advanced diagnostic tests.

This article originally appeared on Engadget at https://www.engadget.com/science/the-fda-clears-the-first-blood-test-for-diagnosing-alzheimers-disease-201209676.html?src=rss

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ยฉ Leon Neal via Getty Images

LONDON, ENGLAND - MAY 20: Blood vials containing personal messages from families affected by the infected blood scandal are seen in a memorial installation within Methodist Central Hall ahead of the release of the findings of the six-year inquiry on May 20, 2024 in London, England. The findings of the official inquiry into the Infected Blood Scandal are published today by chair, Sir Brian Langstaff. Tens of thousands of people are estimated to have received contaminated blood through medical products in the 1970s and 1980s, resulting in the deaths of 3000. The government is also set to announce a ยฃ10bn compensation pot. (Photo by Leon Neal/Getty Images)
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