US regulators have approved the first blood test to help diagnose Alzheimer’s disease, potentially making it easier to find and treat patients with the condition.
The US Food and Drug Administration has cleared Fujirebio Diagnostics’ blood test for people over 55 years of age and those who exhibit symptoms of the disease.
Fujirebio’s test, called Lumipulse, looks at two proteins in the blood and uses their ratio to find signs of amyloid beta plaque, which is an important sign of Alzheimer’s disease.
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Currently, patients either get a specialised PET scan to detect amyloid in their brains or undergo a cerebrospinal fluid test. The PET scans are expensive and require specialised equipment, whereas the spinal fluid tests involve invasive procedures.
Fujirebio’s test only requires a blood draw, making it less invasive and potentially easier for patients to access. It’s unclear how much it will cost or when it will be available. The FDA intends it for patients in a specialised care setting who are experiencing cognitive decline.
The FDA said the blood test shouldn’t be the only diagnostic tool due to the risk of false results. Instead, it should be combined with other clinical assessments and tests to guide treatment decisions. Alzheimer’s disease is a progressive brain disorder that slowly destroys memory, thinking skills, and the ability to carry out simple tasks. It’s the most common cause of dementia, primarily affecting older adults.
