First Blood Test For Alzheimer’s Detection Approved
U.S. health regulators have approved the first blood test designed to assist in diagnosing Alzheimer’s disease, marking a significant advancement in identifying patients who might benefit from certain treatments that modestly slow the condition’s progression. This newly authorized test is meant for individuals aged 55 and older who are experiencing early signs of cognitive decline. It offers a simpler and less invasive method for detecting Alzheimer’s compared to previous options like spinal fluid analysis or PET scans.
The test, developed by Fujirebio Diagnostics, Inc., works by identifying beta-amyloid, a protein associated with the brain plaque commonly found in individuals with Alzheimer’s disease. By confirming the presence of this biomarker, doctors can better determine whether memory problems stem from Alzheimer’s or another condition that affects brain function.
Alzheimer’s disease, the most prevalent form of dementia, affects over 6 million Americans, with many more cases worldwide. The approval of this test could also help increase access to recently approved treatments like Leqembi and Kisunla. These medications work by targeting beta-amyloid and have shown some ability to slow the disease’s progression. However, before prescribing these drugs, physicians must confirm the presence of amyloid plaques, a process now made easier and potentially more accessible through the new blood test.
Although some specialized clinics have already been using their own unregulated amyloid blood tests, those versions haven’t undergone FDA review and often lack insurance coverage. This has created an inconsistent testing environment, raising concerns about reliability and oversight. The newly approved test may help bring more consistency to the diagnostic process.
Additional companies, including Roche, Eli Lilly, and C2N Diagnostics, are also working on similar blood tests aimed at gaining FDA approval. It’s important to note that this new test is only available with a doctor’s order and is not intended for individuals without cognitive symptoms.
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