First blood test to help detect Alzheimer’s approved in the U.S.

Washington, D.C. (EFE) – The U.S. Food and Drug Administration (FDA) announced the approval of the first testing system to detect levels of two proteins associated with the development of Alzheimer’s disease in blood samples.

The Lumipulse G plasma pTau217/ß-Amyloid 1-42 ratio test helps detect the possible development of amyloid plaques in the brain in patients over 55 years of age. These are protein deposits whose appearance is linked to the neuronal degeneration characteristic of Alzheimer’s.

Although amyloid plaques are also associated with other diseases, their presence is a hallmark of Alzheimer’s, and their most common detection is 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 procedure.

The newly approved test allows the detection of levels of these two proteins in plasma with a simple blood draw, 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 had inconclusive results, while 91.7% of people who tested positive for high levels of the two aforementioned proteins also had amyloid plaques confirmed by PET or CSF testing for the aforementioned proteins.

97.3% of those who tested negative also had negative results on the other two tests.

The FDA emphasizes, however, that the system, developed by the Japanese biotechnology company 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.