FDA approves groundbreaking blood test for Alzheimer's diagnosis

In May 2023, the U.S. Food and Drug Administration (FDA) approved the first blood test to assist in diagnosing Alzheimer’s disease. This significant advancement comes as Alzheimer’s continues to affect an estimated 6.7 million Americans, with that number projected to double by 2060. Previously, the existing methods for diagnosing the condition involved invasive procedures, including spinal taps and costly PET scans. The new blood test, developed by Fujirebio Diagnostics, targets distinguishing the presence of amyloid plaques, a hallmark of Alzheimer’s, through a simple blood sample. The new diagnostic method analyzes two proteins in the blood: pTau217 and β-amyloid 1-42. An improved testing format is expected to simplify the diagnostic process for patients aged 55 and older who exhibit early symptoms, as traditional methods required extensive and financially burdensome tests that often delayed diagnosis. The FDA has indicated that this blood test can reliably predict amyloid pathology linked to Alzheimer’s disease and thus significantly enhances the accessibility of early diagnostic capabilities. Moreover, the new test could facilitate timely treatment interventions using newly approved drugs, such as Leqembi and Kisunla, known to modestly slow the progression of Alzheimer’s by clearing amyloid from the brain. Doctors are now instructed to conduct this preliminary blood test before prescribing these medications, effectively making the management of patients’ cognitive health more proactive. This approval marks a transformative milestone in Alzheimer’s diagnosis, addressing a significant need for easier and more accessible testing methods. Experts, including Dr. Michelle Tarver from the FDA, have expressed optimism about this new approach, indicating its potential to streamline the diagnostic process for older adults. However, it is crucial to note that while this blood test offers a promising first step, the FDA acknowledges the need for further clinical information and testing to confirm diagnoses accurately, as false positives and negatives remain a risk. The medical community is hopeful that these advancements will help manage the rising Alzheimer’s patient population effectively and lead to improved health outcomes.