Alzheimer’s is most often diagnosed when its symptoms significantly impede everyday functioning. However, the disease is already at an advanced stage, and alleviating its symptoms is very difficult. Therefore, early diagnostics is a hope, and a breakthrough has just taken place in this area. The US Food and Drug Administration (FDA) has approved an innovative diagnostic test that can help detect Alzheimer’s disease when it is not yet symptomatic.
- The Lumipulse G β-Amyloid Ratio 1-42 / 1-40 test is able to detect amyloid plaques, called senile plaques – changes in the structure of the brain, for Alzheimer’s disease
- The test can detect the disease in people as early as 55 years old
- New diagnostic method could completely eliminate the need to scan the brain with PET – positron emission tomography using radioisotope techniques
- The safety and effectiveness of the test was positively assessed by the US FDA
- More information can be found on the Onet homepage
Rapid Alzheimer’s Test
The Lumipulse G β-Amyloid Ratio 1-42 / 1-40 test detects amyloid plaques associated with Alzheimer’s disease in adults 55 years of age and older who are diagnosed with this condition or other causes of cognitive decline.
The test measures the ratio of beta-amyloid 1-42 and beta-amyloid 1-40 concentrations in the cerebrospinal fluid, which can be detected, among others, by using PET, i.e. positron emission tomography. This is one of the basic diagnostic methods currently used in the diagnosis of Alzheimer’s disease, which, while effective, has two major drawbacks: it is time-consuming and expensive. Test firmy Fujirebio Diagnostics can be performed in one day, and you do not have to wait long for the result, which is a definite advantage over existing tests.
“Thanks to the Lumipulse test, we have a new test that can be performed in one day and that can give doctors the same information about the presence of amyloid in the brain [as the PET test – ed.], But without the risk of radiation,” said Dr. Jeff Shuren, director of the Center for Devices and FDA Radiological Health, quoted in a statement from the agency.
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Breakthrough invention
The FDA conducted a clinical trial in which it assessed the safety and effectiveness of the Lumipulse test. For this purpose, 292 CSF samples were collected from the Alzheimer’s Disease Neuroimaging Initiative. They were tested with a new diagnostic tool and the results were compared with those of a PET scan.
In 97 percent people with a positive Lumipulse test amyloid plaques were also detected in the PET test, while 84 percent. of subjects with a negative result in the new test, such a result was also obtained in positron emission tomography.
Regarding safety, the new method of diagnosing Alzheimer’s is non-invasive, and the only risk with performing the test is the possibility of false-positive or false-negative results. For this reason, the American agency recommends that Lumipulse should always be used in conjunction with other diagnostic methods.
The Lumipulse test has been awarded the “breakthrough device” designation by the FDA. This label is given to discoveries that can provide a more effective diagnosis or treatment for life-threatening and / or irreversible health conditions.
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