US FDA clears first-ever blood test to help diagnose Alzheimer’s disease
The US Food and Drug Administration (FDA) has approved the first blood test to help diagnose Alzheimer’s disease. Called the Lumipulse test, it is meant for people aged 55 and above who show signs of memory loss or cognitive issues.The test aims to detect amyloid plaques – a hallmark of Alzheimer’s – using a simple blood sample, offering a less invasive, more accessible, and cost-effective alternative to PET scans (Positron Emission Tomography), which are typically used to detect amyloid buildup but are expensive and involve radiation exposure.“Alzheimer’s disease impacts too many people – more than breast and prostate cancer combined,” said FDA Commissioner Dr Martin A Makary. “With 10% of people aged 65 and older affected, and that number expected to double by 2050, I’m hopeful that new tools like this test will improve early detection and care.”Alzheimer’s disease is a progressive disorder that slowly erodes memory and thinking skills. Early diagnosis is key to managing symptoms and planning treatment. While PET scans have been the gold standard for confirming amyloid presence, this new blood test offers a reliable alternative in patients showing signs of cognitive impairment.However, the FDA has cautioned that the test is intended only for use in specialised care settings and should be interpreted alongside other clinical assessments. False positives may lead to misdiagnosis, unnecessary treatments, emotional distress, and delays in identifying the correct condition.The approval of the Lumipulse blood test marks a major step forward in Alzheimer’s diagnostics, potentially paving the way for broader screening and earlier interventions in the fight against the disease.
The US Food and Drug Administration (FDA) has approved the first blood test to help diagnose Alzheimer’s disease. Called the Lumipulse test, it is meant for people aged 55 and above who show signs of memory loss or cognitive issues.
The test aims to detect amyloid plaques – a hallmark of Alzheimer’s – using a simple blood sample, offering a less invasive, more accessible, and cost-effective alternative to PET scans (Positron Emission Tomography), which are typically used to detect amyloid buildup but are expensive and involve radiation exposure.
“Alzheimer’s disease impacts too many people – more than breast and prostate cancer combined,” said FDA Commissioner Dr Martin A Makary. “With 10% of people aged 65 and older affected, and that number expected to double by 2050, I’m hopeful that new tools like this test will improve early detection and care.”
Alzheimer’s disease is a progressive disorder that slowly erodes memory and thinking skills. Early diagnosis is key to managing symptoms and planning treatment. While PET scans have been the gold standard for confirming amyloid presence, this new blood test offers a reliable alternative in patients showing signs of cognitive impairment.
However, the FDA has cautioned that the test is intended only for use in specialised care settings and should be interpreted alongside other clinical assessments. False positives may lead to misdiagnosis, unnecessary treatments, emotional distress, and delays in identifying the correct condition.
The approval of the Lumipulse blood test marks a major step forward in Alzheimer’s diagnostics, potentially paving the way for broader screening and earlier interventions in the fight against the disease.
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