Health
FDA approves diagnostic test for early Alzheimer’s disease
May 5, 2022 – The FDA has cleared the first in vitro diagnosis to support early detection of Alzheimer’s disease (AD).
The Lumipulse Gβ-Amyloid Ratio 1-42 / 1-40 (Fujirebio Diagnostics) test detects AD-related amyloid plaques in adults aged 55 years and older who are investigating the causes of AD and other cognitive decline.
“Availability of in vitro diagnostic tests that can potentially eliminate time-consuming and costly needs [positron emission tomography (PET)] The scan is great news for individuals and families concerned about the potential diagnosis of Alzheimer’s disease, “said Jeff Schlenn, MD, director of the FDA’s Device and Radiation Health Center.
“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. Helps. “He said.
In that statement, the FDA states that “there is an unmet need for a reliable and safe test that can accurately identify patients with amyloid plaques consistent with Alzheimer’s disease.”
Authorities also said the new test could eliminate the need to use PET brain scans, a “potentially costly and cumbersome option” for visualizing amyloid plaques for the diagnosis of AD. I am saying.
The Lumipulse test measures the ratio of β-amyloid 1-42 to β-amyloid 1-40 concentrations in human cerebrospinal fluid (CSF). Positive Lumipulse Gβ-amyloid ratio (1-42 / 1-40) test results are consistent with the presence of amyloid plaques similar to those revealed by PET scans. Negative results are consistent with negative amyloid PET scan results.
However, the FDA states that this test is not an independent assay and should be used in combination with other clinical evaluations and additional tests to determine treatment options.
The FDA reports that it evaluated the safety and efficacy of the test in a clinical study of 292 CSF samples from the Alzheimer’s Disease Neuroimaging Initiative Sample Bank.
Samples were tested by Lumipulse Gβ-amyloid ratio (1-42 / 1-40) and compared with the results of amyloid PET scans. In this clinical study, 97% of individuals who tested positive for the Lumipulse Gβ-amyloid ratio (1-42 / 1-40) showed the presence of amyloid plaques on PET scans, and 84% of individuals who tested negative. However, the amyloid PET scan was negative. ..
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.
False positive results, along with other clinical information, can lead to inadequate diagnosis and unnecessary treatment of AD.
False-negative test results can lead to additional unnecessary diagnostic tests and delay effective treatment of AD.
FDA Also Pre-marketing review pathways, new types of low-risk to medium-risk device regulatory pathways.
Authorities have stated that this action “creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510 (k) premarket process. The device can obtain marketing approval by demonstrating substantial equivalence with the predicate. Terminal. “
Lumipulse Gβ-amyloid ratio (1-42 / 1-40) was given Breakthrough device A process designed to facilitate the development and review of devices that may provide more effective treatment or diagnosis of designated, life-threatening or irreversibly debilitating diseases or conditions.
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Sources 2/ https://www.webmd.com/alzheimers/news/20220505/fda-oks-diagnostic-test-early-alzheimers The mention sources can contact us to remove/changing this article |
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