FDA Clears for Marketing a Diagnostic Device That Tests Blood to Aid Diagnosing Alzheimer's

The FDA has cleared for marketing “the first in vitro diagnostic device that tests blood to aid in diagnosing Alzheimer’s disease.”

The device, the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, is for the “early detection of amyloid plaques associated with Alzheimer’s disease in adult patients, aged 55 years and older, exhibiting signs and symptoms of the disease.” Amyloid plaques in a patient’s brain are a “hallmark sign of Alzheimer’s disease. While amyloid plaques can occur in other diseases, being able to detect the presence of plaque, along with other evaluations, helps the doctor determine the probable cause of the patient’s symptoms and findings.” They can be detected with PET scans, but those are a “costly and time-consuming option and expose patients to radiation.”

The product cleared for marketing measures two proteins found in human plasma and “calculates the numerical ratio of the levels of the two proteins.” The ratio is “correlated to the presence or absence of amyloid plaques in the patient’s brain, reducing the need for a PET scan.” This new Lumipulse test only “requires a simple blood draw” as opposed to the spinal tap required by similar FDA-authorized tests.

A clinical study showed that 91.7% of people with positive results from the Lumipulse test had the presence of amyloid plaques by PET scan or other tests, and 97.3% with negative results did not have the presence of plaques. This demonstrates the test’s effectiveness. The main risks associated with the test, however, remain “the possibility of false positive and false negative test results.”