FDA approves marketing for new Alzheimer's early detection test

The Food and Drug Administration has approved marketing for the first in vitro diagnostic test for early detection of Alzheimer’s disease.

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The Lumipulse G β-Amyloid Ratio (1-42/1-40) test is available at clinical laboratories nationwide for adult patients aged 55 years and older who are presenting with cognitive impairment and being evaluated for Alzheimer’s disease and other causes of cognitive decline. 

The test, which is developed by Fujirebio Diagnostics Inc., is intended to measure the ratio of β-amyloid 1-42 and β-amyloid 1-40 proteins found in human cerebral spinal fluid, which can help physicians determine whether a patient is likely to have amyloid plaques. β-amyloid plaques are believed to contribute to the loss of cognitive function that characterizes Alzheimer's disease.

Prior to the marketing authorization, doctors used positron emission tomography (PET) scans, a potentially costly and time-consuming option, to detect and visualize amyloid plaques in a patient’s brain and help diagnose Alzheimer's disease years before clinical symptom onset.

"With the Lumipulse test, there is a new option that can typically be completed the same day and can give doctors the same information regarding brain amyloid status, without the radiation risk, to help determine if a patient’s cognitive impairment is due to Alzheimer’s disease," Jeff Shuren, the FDA's director for the Center for Devices and Radiological Health, said in a statement.  

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A positive Lumipulse G β-amyloid Ratio (1-42/1-40) test result is consistent with the presence of amyloid plaques, similar to what would be seen in a PET scan. A negative result is consistent with a negative amyloid PET scan result, reducing the likelihood that a patient’s cognitive impairment is due to Alzheimer’s disease and enabling physicians to pursue other causes of cognitive decline and dementia. 

An FDA clinical study of 292 cereal spinal fluid samples from the Alzheimer’s Disease Neuroimaging Initiative sample bank tested by the Lumipulse G β-amyloid Ratio (1-42/1-40) and compared with amyloid PET scan results found 97% of patients with positive results had the presence of amyloid plaques by PET scan, compared to 84% of individuals with negative test results who had a negative amyloid PET scan.

The risks associated with the Lumipulse G β-amyloid Ratio (1-42/1-40) test are mainly the possibility of false positive and false negative test results. The test is not intended as a screening or stand-alone diagnostic assay and should be used with other clinical evaluations or additional tests to determine treatment options. 

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According to the Alzheimer's Association, an estimated 6.5 million Americans age 65 and older are living with Alzheimer's disease, with approximately 73% who are age 75 or older. By 2050, the figure is projected to rise to nearly 12.7 million Americans. 

About 1 in 3 seniors die with Alzheimer's or another dementia, killing more people than breast cancer and prostate cancer combined. Deaths from Alzheimer’s have more than doubled between 2000 and 2019, while those from heart disease – the leading cause of death – have decreased. People who are 65 and older survive an average of four to eight years after a diagnosis of Alzheimer’s, though some can live as long as 20 years with the disease.

In 2022, Alzheimer's and other dementias will cost the nation $321 billion, including $206 billion in Medicare and Medicaid payments combined. Unless a treatment to slow, stop or prevent the disease is developed, Alzheimer's is projected to cost nearly $1 trillion by 2050.