United States: A new blood test used to diagnose Alzheimer’s disease is now clear for marketing by the US Food and Drug Administration, becoming the first to receive such approval in the country.
Between the ages of 55 and 85, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio can be administered to help diagnose adults with Alzheimer’s symptoms, the FDA stated Friday.
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Two proteins in blood plasma, pTau217 and beta-amyloid 1-42, are analyzed to work this way.
The level of those proteins can be related to amyloid plaques, which often appear in the brains of Alzheimer’s disease patients, USA Today reported.
The test is able to spot signs that support amyloid in the brain, even indirectly.
The FDA green-lit a blood test to detect plaques in the brain associated with Alzheimer’s disease, providing a less risky and more accessible tool to help diagnose the neurodegenerative condition. https://t.co/R70fXYDVGW
— The Washington Post (@washingtonpost) May 16, 2025
However, at this time, a single test cannot be used to diagnose Alzheimer’s disease.
Generally, doctors use medical history, exams of the nerves, tests of thinking and function, pictures of the brain, analysis of spinal fluid, and in some cases, blood tests to diagnose Parkinson’s.
According to the FDA, the results from this test must be reviewed together with other medical information about a patient.
According to FDA Commissioner Dr. Martin Makary, “Alzheimer’s disease impacts too many people, more than breast cancer and prostate cancer combined,” USA Today reported.
“Knowing that 10% of people aged 65 and older have Alzheimer’s, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients,” Makary added.
