FDA Clears First Blood Test to Aid in Diagnosing Alzheimer's Disease

The US Food and Drug Administration (FDA) has cleared for marketing the first in vitro diagnostic device that tests blood to aid in diagnosing Alzheimer's disease. The Lumipulse G pTau217/b-Amyloid 1-42 Plasma Ratio, developed by Fujirebio Diagnostics, Inc., measures two proteins found in human plasma and calculates the numerical ratio of their levels to detect amyloid plaques associated with Alzheimer's disease. This new test is a game-changer in the early detection of Alzheimer's, which is a progressive brain disorder that slowly destroys memory and thinking skills.

Key Takeaways:

• The Lumipulse G pTau217/b-Amyloid 1-42 Plasma Ratio is the first FDA-cleared blood test to aid in diagnosing Alzheimer's disease.
• The test measures the levels of pTau217 and β-amyloid 1-42 proteins found in human plasma and calculates their ratio to detect amyloid plaques.
• A multi-center clinical study of 499 individual plasma samples showed that the test had a 91.7% sensitivity and 97.3% specificity in detecting amyloid plaques.
• The test is intended for patients presenting at a specialized care setting with signs and symptoms of cognitive decline.
• The test is not intended as a screening or stand-alone diagnostic test and should be used in conjunction with other clinical evaluations or additional tests.
• The risks associated with the Lumipulse G pTau217/b-Amyloid 1-42 Plasma Ratio include the possibility of false positive and false negative test results.

Statistics:

• 91.7% of individuals with Lumipulse G pTau217/b-Amyloid 1-42 Plasma Ratio positive results had the presence of amyloid plaques by PET scan or CSF test result.
• 97.3% of individuals with Lumipulse G pTau217/b-Amyloid 1-42 Plasma Ratio negative results had a negative amyloid PET scan or CSF test result.
• Less than 20% of the 499 patients tested received an indeterminate Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio result.

Sources:

• FDA News Release, "FDA clears first blood test to aid in diagnosing Alzheimer's disease"
• Lumipulse G pTau217/b-Amyloid 1-42 Plasma Ratio, User Instructions, Fujirebio Diagnostics, Inc.