FDA Approves First Blood Test for Alzheimer’s Diagnosis

On May 16, 2025, the U.S. Food and Drug Administration (FDA) approved the first blood test designed to aid in the diagnosis of Alzheimer’s disease. The Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test, developed by Fujirebio Diagnostics, measures the ratio of two plasma proteins — pTau217 and β-amyloid 1-42 — associated with the presence of amyloid plaques in the brain, one of the key biomarkers of the disease.

Intended for adults aged 55 and older who present with signs and symptoms consistent with Alzheimer’s disease, the test represents a less invasive alternative to traditional methods such as lumbar puncture and positron emission tomography (PET). Requiring only a blood sample, the test facilitates early diagnosis while reducing patient exposure to radiation and invasive procedures.

The approval of the Lumipulse test is considered a major step forward in Alzheimer’s diagnostic strategies, especially in light of the projected increase in disease prevalence. Currently, about 10% of Americans aged 65 or older live with Alzheimer’s, a number that could double by 2050. The FDA emphasized that less invasive testing options could expand access to diagnosis and enable earlier therapeutic interventions.

It is important to note that the test is not intended for use in asymptomatic individuals, due to the potential for false-positive or false-negative results. The presence of amyloid plaques should always be interpreted in conjunction with clinical evaluations and additional diagnostic assessments for an accurate conclusion.

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