FDA Clears First In Vitro Diagnostic Device for Early Detection of Alzheimer's Disease

The U.S. Food and Drug Administration has cleared the Lumipulse G pTau217/È-Amyloid 1-42 Plasma Ratio for marketing, a device that tests blood to aid in diagnosing Alzheimer's disease. This marks a significant step forward in the early detection and diagnosis of the disease, which affects more than 7 million Americans and is projected to rise to nearly 13 million. The device measures two proteins found in human plasma and calculates their numerical ratio, indicating the presence or absence of amyloid plaques in the brain.

Key Takeaways:

• The Lumipulse G pTau217/È-Amyloid 1-42 Plasma Ratio is the first in vitro diagnostic device approved for the early detection of Alzheimer's disease in adult patients aged 55 and older.
• The device measures two proteins, pTau217 and ð-amyloid 1-42, found in human plasma, and calculates their numerical ratio to detect amyloid plaques in the brain.
• The device is intended for patients presenting at a specialized care setting with signs and symptoms of cognitive decline, and results must be interpreted in conjunction with other patient clinical information.
• The FDA reviewed the Lumipulse G pTau217/È-Amyloid 1-42 Plasma Ratio through the 510(k) premarket notification pathway, which demonstrated substantial equivalence to a previously authorized test that uses cerebrospinal fluid samples.
• The device was granted Breakthrough Device designation, a process designed to expedite the development and review of devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
• The FDA evaluated data from a multi-center clinical study of 499 individual plasma samples, which showed that 91.7% of individuals with positive Lumipulse G pTau217/È-Amyloid 1-42 Plasma Ratio results had the presence of amyloid plaques, and 97.3% of individuals with negative results had a negative amyloid PET scan or CSF test result.
• The device's accuracy is 91.7% for amyloid positive and 97.3% for amyloid negative. Less than 20% of the patients tested received an indeterminate result.

Statistics:

• 7 million Americans are living with Alzheimer's disease.
• The number of Americans with Alzheimer's is projected to rise to nearly 13 million.
• 10% of people aged 65 and older have Alzheimer's disease.
• By 2050, the number of people with Alzheimer's disease is expected to double.
• 91.7% of individuals with positive Lumipulse G pTau217/È-Amyloid 1-42 Plasma Ratio results had the presence of amyloid plaques.
• 97.3% of individuals with negative Lumipulse G pTau217/È-Amyloid 1-42 Plasma Ratio results had a negative amyloid PET scan or CSF test result.

Sources:

• U.S. Food and Drug Administration
• FDA, 2025
• US Department of Health and Human Services, 2025
• Contify.com