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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 Ξ²-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 Ξ²-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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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 Β£10bn compensation pot. (Photo by Leon Neal/Getty Images)

A bonus from the shingles vaccine: Dementia protection?

3 April 2025 at 14:39

A study released on Wednesday finds that a live-virus vaccine that limits shingles symptoms was associated with a drop in the risk for dementia when it was introduced. The work took advantage of the fact that the National Health Service Wales made the vaccine available with a very specific age limit, essentially creating two populations, vaccinated and unvaccinated, separated by a single date. And these populations showed a sharp divide in how often they were diagnosed with dementia, despite having little in the way of other differences in health issues or treatments.

What a day

This study didn't come out of nowhere. There have been a number of hints recently that members of the herpesvirus family that can infect nerve cells are associated with dementia. That group includes Varicella zoster, the virus that causes both chicken pox andβ€”potentially many years afterβ€” shingles, an extremely painful rash. And over the past couple of years, observational studies have suggested that the vaccine against shingles may have a protective effect.

But it's extremely difficult to do a clinical trial given that the onset of dementia may happen decades after most people first receive the shingles vaccine. That's why the use of NHS Wales data was critical. When the first attenuated virus vaccine for shingles became available, it was offered to a subset of the Welsh population. Those who were born on or after September 2, 1933, were eligible to receive the vaccine. Anyone older than that was permanently ineligible.

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