FDA Approves Blood Test to Detect Alzheimer's Plaques in the Brain

The Food and Drug Administration (FDA) has green-lit a blood test called Lumipulse to detect plaques in the brain associated with Alzheimer's disease. This non-invasive test measures two proteins found in plasma to determine whether a patient has amyloid plaques in the brain, a hallmark of Alzheimer's disease. The Lumipulse test takes a simple blood draw, making it easier and more accessible than existing methods that involve costly and more invasive tests such as spinal taps and brain scans.

Key Takeaways:

• The FDA cleared Lumipulse, a blood test developed by Fujirebio Diagnostics, to detect amyloid plaques in the brain associated with Alzheimer's disease.
• The test measures two proteins found in plasma and is intended for patients at least 55 years old with symptoms of cognitive decline.
• Lumipulse is the first blood test to receive FDA clearance, joining existing laboratory-developed blood tests that are not reviewed by the agency.
• Privately held companies, C2N Diagnostics and Quanterix, are also developing blood-based tests for Alzheimer's disease.
• Experts believe that the availability of blood tests like Lumipulse will dramatically change clinical care for patients with symptoms of Alzheimer's disease.
• The presence of amyloid plaques is a hallmark of Alzheimer's disease, but the role it plays is a matter of debate among neurologists.
• The FDA has approved three anti-amyloid drugs since 2021, including Kisunla, Leqembi, and Aduhelm, which can modestly slow the disease's progression but not reverse it.
• There is no cure for Alzheimer's disease, and medications to treat the disease have been fraught with complications such as bleeding in the brain.

Statistics:

• 7 million Americans are affected by Alzheimer's disease (Rampant competition among companies delivering next-generation tests to diagnose Alzheimer's).
• The Lumipulse test was cleared based on a clinical study of 499 plasma samples from patients with cognitive impairment.
• 91.7% of patients who tested positive for the presence of amyloid were confirmed to have the plaques by brain scans or spinal tap procedures (Main risks of the Lumipulse test are false positives and false negatives).
• 97.3% of patients with negative results were similarly confirmed not to have the plaques.

Sources:

• Daniel Gilbert; Rachel Roubein
• The Food and Drug Administration