Blood test for Alzheimer's: What US FDA approval means for early diagnosis
The US Food and Drug Administration (FDA) has approved the first blood test for diagnosing Alzheimer's disease, a progressive neurodegenerative disorder that affects brain function and memory. The test, called Lumipulse, was granted breakthrough device approval and is designed for early detection of amyloid plaques associated with Alzheimer's disease in patients aged over 55 who exhibit signs and symptoms.
Made by Fujirebio Diagnostics, the test measures the ratio between two proteins (pTau17 and beta-amyloid 1-42) in human plasma. The ratio is related to the presence of amyloid plaques in the brain that are linked to Alzheimer's.
This test is significant to the extent that amyloid begins to accumulate and form plaques in the brain more than 20 years before any symptoms of cognitive impairment. Tau accumulates later, forming tangles in the brain, and is associated with impairment of brain functions. In that sense this is an early warning system, it allows for much earlier detection of the disease — even before clear memory or behavioural symptoms appear.
However, the test is just indicative, not confirmatory. It has an efficacy of 60 to 70 per cent. The study found that the blood test was nearly 92 per cent as accurate as a PET scan or a spinal tap. Therefore, it should not be used on its own to diagnose or to rule out Alzheimer's. Other clinical evaluations, like imaging or additional tests, should be used for determining treatment options. The FDA itself has said that results must be interpreted in conjunction with other patient clinical information.
Early diagnosis gives patients and families more time to understand the condition, plan care and consider available treatments or clinical trials. It can also help rule out Alzheimer's when symptoms are caused by other, potentially treatable conditions. Moreover, making this test widely available in primary care settings can help close the gap in diagnosis for people in underserved or remote areas. Overall, this development could make Alzheimer's diagnosis more timely, accurate and accessible for millions of people worldwide
The test helps in how we diagnose and manage this condition. Until now, confirming a diagnosis of Alzheimer's typically required specialised procedures like PET brain scans or a lumbar puncture to test spinal fluid. These methods, while effective, are invasive, expensive and often not available in smaller hospitals or rural areas.
By detecting biomarkers through a simple blood sample, doctors can now evaluate patients in a faster, less invasive and more affordable way.
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