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FDA Clears First Blood Test for Early Detection of Alzheimer's Disease

Strategic Insights

— 1 min read

The US Food and Drug Administration (FDA) has cleared the Lumipulse G pTau217/È-Amyloid 1-42 Plasma Ratio (by Fujirebio Diagnostics, Inc.) for marketing, a game-changing in vitro diagnostic device that uses blood tests to aid in diagnosing Alzheimer's disease. This innovative test measures two proteins found in human plasma, pTau217 and ð-amyloid 1-42, and calculates their numerical ratio to correlate with the presence or absence of amyloid plaques in the brain. Unlike traditional tests that require cerebrospinal fluid samples collected through a spinal tap, this new blood test is less invasive and easier for patients to access, making it a more accessible option for diagnosing Alzheimer's disease.

Key Takeaways:

  • The Lumipulse G pTau217/È-Amyloid 1-42 Plasma Ratio is the first in vitro diagnostic device cleared by the FDA to test blood for the early detection of Alzheimer's disease.
  • The test measures the numerical ratio of two proteins, pTau217 and ð-amyloid 1-42, found in human plasma, and correlates with the presence or absence of amyloid plaques in the brain.
  • This new blood test reduces the reliance on PET scans, making it a less invasive and more accessible option for patients.
  • The test is intended for patients presenting at a specialized care setting with signs and symptoms of cognitive decline.
  • Results must be interpreted in conjunction with other patient clinical information.
  • Fujirebio Diagnostics, Inc., the company behind the new test, has developed similar FDA-authorized/cleared tests using cerebrospinal fluid samples.

Statistics:

  • The Lumipulse G pTau217/È-Amyloid 1-42 Plasma Ratio has been cleared by the FDA for marketing.
  • The test is licensed for use in adult patients aged 55 years and older.
  • Over 5.8 million people in the US are estimated to have Alzheimer's disease, with many cases undiagnosed or misdiagnosed.
  • The new blood test can predict the presence or absence of amyloid pathology associated with Alzheimer's disease at the time of the test in patients who are cognitively impaired.
  • Alzheimer's disease is the fifth leading cause of death in the US.

Sources:

  • FDA Clears First In-Vitro Diagnostic Device to Aid in Alzheimer's Disease Diagnosis. (2025 MM Activ Sci-Tech Communications Pvt. Ltd., distributed by Contify.com)

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