First Blood Test for Alzheimer's Cleared by FDA
- Stephanie Soto
- Jun 15
- 2 min read
The Food and Drug Administration (FDA) recently cleared the first blood test for Alzheimer's disease. This test (The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio) looks for amyloid plaques, which are clumps of protein that are the hallmark for Alzheimer's disease. Blood tests have been used in clinical trials for years, but it has finally been cleared to use as a diagnostic test with the general population. Let's learn more.
This test is cleared to use in people 55 years old and older when showing signs consistent with Alzheimer's disease. Per the FDA, "The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio measures two proteins, pTau217 and β-amyloid 1-42, found in human plasma, a component of blood, and calculates the numerical ratio of the levels of the two proteins. This ratio is correlated to the presence or absence of amyloid plaques in the patient’s brain, reducing the need for a PET scan." Currently, it is being used at the "first pass detection tool" meaning this test is performed first and if positive, further testing will be done. It is expected to be available later this month.
What does this mean for PD?
In 2023, a biomarker to detect alpha-synuclean, the hallmark of PD, was validated in spinal fluid. Currently, researches are working towards developing and validating that test for skin and blood samples. The approval of a blood test for Alzheimer's is a huge step forward for PD testing. MJFF chief scientist Mark Frasier, PhD says “the approval of a blood test in Alzheimer’s is an important milestone for neurodegenerative diseases broadly, and it provides a path to follow for Parkinson’s research.”
Early and accurate diagnoses for both PD and Alzheimer's is crucial. With both diseases, researchers believe that the disease starts years before symptoms are shown. Blood tests can help those who are most at risk obtain early screening and treatment.
If you think you are exhibiting signs of Alzheimer's and/or Parkinson's, speak with your doctor.
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