EU approves first blood test to aid in Alzheimer's detection

This Friday, the so-called Food and Drug Administration (FDA), the United States government agency responsible for regulating food, medicines, cosmetics, medical devices, biological products and blood products, announced that the first testing system that allows the detection of two proteins associated with the development of Alzheimer's disease in blood samples has been approved.

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According to the report, the test known as Lumipulse G for plasma pTau217/ß-Amyloid 1-42 ratio may be useful for early detection in subjects over 55 years of age, of amyloid plaques in the brain, which are protein deposits whose appearance is related to the neuronal degeneration typical of Alzheimer's.

And although amyloid plaques are also linked to other types of diseases, their presence has been proven to be a hallmark of Alzheimer's , and they are most commonly detected through positron emission tomography (PET) scans, an expensive option that involves radiation exposure.

In turn, the detection of the proteins pTau217 and β-Amyloid 1-42, two biomarkers associated with the development of amyloid plaques in the brain, is possible through the analysis of cerebrospinal fluid (CSF), which is obtained through a lumbar puncture, an invasive and painful process.

The newly approved test allows the levels of these two proteins in plasma to be detected with a simple blood draw, thereby reducing the need for PET scanning. contributing to possible earlier diagnoses.

To approve this testing kit , the FDA evaluated data from a clinical study using 499 individual blood samples from adult patients with cognitive disabilities.

Less than 20% of the samples tested yielded inconclusive results, while 91.7% of those who tested positive for high levels of the two aforementioned proteins also had amyloid plaques confirmed by PET or the aforementioned proteins confirmed by CSF testing.

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97.3% of those who obtained a negative result also had negative results in the other two tests.

In any case, the FDA insists that the system, developed by the Japanese biotechnology laboratory Fujirebio and intended for patients with symptoms of cognitive impairment, cannot be used as a sole diagnostic test, and therefore its results must be combined with other tests or additional evaluations.

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