FDA’s Blood Test Approval Makes the Fight Against Alzheimer’s Faster, Less Invasive, and More Accurate

For years, inconvenient and costly PET imaging scans and invasive spinal taps were the go-to for Alzheimer’s diagnoses. Last week, the FDA approved a new blood test, developed by a Japan-based company, Fujirebio Diagnostics.

“Alzheimer’s disease impacts too many people, more than breast cancer and prostate cancer combined,” said FDA Commissioner Martin A. Makary, M.D., M.P.H. “Knowing that 10% of people aged 65 and older have Alzheimer's, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients.”

The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio measures and compares the ratio of two proteins found in human plasma, an element of human blood. A similar test had previously been approved to test cerebrospinal fluid (CSF), but it requires an invasive lumbar puncture. The new, less invasive test only requires a simple blood draw and will aid in the early detection of amyloid plaques (clumps of toxic proteins that build up between brain cells) commonly associated with Alzheimer's disease. The Luminpulse test is approved for use in adult patients, aged 55 years and older, exhibiting early signs and symptoms of the disease. Further guidelines on this as it relates to physicians and patient access will be released later this summer; however, we encourage all interested in individuals to talk with their direct physicians for more detailed information.

“Nearly 7 million Americans are living with Alzheimer's disease, and this number is projected to rise to nearly 13 million,” said Center for Devices and Radiological Health Director Michelle Tarver, M.D., Ph.D. “Today’s clearance is an important step for Alzheimer’s disease diagnosis, making it easier and potentially more accessible for U.S. patients earlier in the disease.”

Approval for the test came after the FDA reviewed data from a multi-center clinical study of 499 individual plasma samples from cognitively impaired adults. 91.7% of individuals with positive test results showed the presence of amyloid plaques when also tested by PET scan or CSF. Meanwhile, negative amyloid PET scans and CSF results were found in 97.3% of individuals that received negative results from the blood test.

False positive or negative results appear to be the main risk factor for the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio blood test, resulting in either the psychological distress of an incorrect Alzheimer’s diagnosis or a delay in treatment.

Overall, this new test is a powerful novel weapon in the fight against dementia. With each new breakthrough in testing, more patients can receive a formal Alzheimer’s disease diagnosis early when symptoms may still be mild and more responsive to treatment. While Alzheimer’s disease is the most common form of dementia, we recognize there are still many other forms that need this ease, accuracy, and minimal financial burden of diagnosis testing. We remain more committed than ever to our mission that funds research for all forms of dementia, so that these advancements can be made possible across all dementia disease forms.