FDA approves marketing of new early detection test for Alzheimer’s disease

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Dedham, Massachusetts-October 16: Intern Susan Garner-Titus is an art and music therapy session for Alzheimer patients on October 16, 2008 by Irving’s Newbridge, a resident of Charles Assisted Living. Helping to attend a class called Glued Together as part of.

Food and Drug Administration approves first marketing in vitro diagnostic test For early detection of Alzheimer’s disease.

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The Lumipulse Gβ-Amyloid Ratio (1-42 / 1-40) test is a national clinical study of adult patients aged 55 years and older who present with cognitive dysfunction and have been evaluated for Alzheimer’s disease and other causes of cognitive decline. It can be used at places.

Developed by Fujirebio Diagnostics Inc., this test aims to measure the ratio of β-amyloid 1-42 to β-amyloid 1-40 proteins in human cerebrospinal fluid. This helps doctors determine the patient’s potential. There are amyloid plaques. Beta-amyloid plaques are thought to contribute to the loss of cognitive function that is characteristic of Alzheimer’s disease.

Fujirebio’s fully automated LUMIPULSE® G1200 system analyzes the Lumipulse Gβ-amyloid ratio (1-42 / 1-40) test for Alzheimer’s disease. (Fujirebio Diagnostics Inc / Fox News)

Prior to marketing approval, physicians used a positron emission tomography (PET) scan. It detects and visualizes amyloid plaques in the patient’s brain and helps diagnose Alzheimer’s disease many years before the onset of clinical symptoms.

“The Lumipulse test has a new option that can usually be completed on the same day and provides doctors with the same information about brain amyloid status without the risk of radiation, to determine if a patient’s cognitive impairment is due to Alzheimer’s disease. “It helps,” Jeff Schlen, director of the FDA’s Device and Radiation Health Center, said in a statement.

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Positive Lumipulse Gβ-amyloid ratio (1-42 / 1-40) test results are consistent with the presence of amyloid plaques, similar to those seen on PET scans. Negative results are consistent with negative amyloid PET scan results, reducing the likelihood that a patient’s cognitive dysfunction is due to Alzheimer’s disease and allowing physicians to pursue other causes of cognitive decline and dementia.

In an FDA clinical study of 292 grain spinal fluid samples from the Alzheimer’s disease neuroimaging initiative sample bank tested by the Lumipulse Gβ-amyloid ratio (1-42 / 1-40) and compared to amyloid PET scan results, 97 of positive patients. % Was found The results showed the presence of amyloid plaques with PET scans compared to 84% of individuals with negative amyloid PET scans.

The risks associated with the Lumipulse Gβ-amyloid ratio (1-42 / 1-40) test are primarily the possibility of false positive and false negative test results. This test is not intended for screening or independent diagnostic assays and should be used in combination with other laboratory evaluations or additional tests to determine treatment options.

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by Alzheimer’s AssociationAn estimated 6.5 million Americans over the age of 65 have Alzheimer’s disease, and about 73% are over the age of 75. By 2050, this figure is projected to increase to about 12.7 million Americans.

About one in three elderly people die of Alzheimer’s disease or another dementia, and more than the combined breast and prostate cancers die. Deaths from Alzheimer’s disease more than doubled between 2000 and 2019, but deaths from heart disease, the leading cause of death, are declining. People over the age of 65 live on average 4-8 years after being diagnosed with Alzheimer’s disease, but some can live for as long as 20 years with Alzheimer’s disease.

In 2022, Alzheimer’s disease and other dementias will cost $ 321 billion, including $ 206 billion for Medicare and Medicaid payments combined. Alzheimer’s disease is projected to cost nearly $ 1 trillion by 2050 unless treatments are developed to delay, stop, or prevent the disease.

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