Destined to patients with cognitive impairment, the Japanese company Fujirebio developed a blood test capable of identifying this accumulation, a key marker of the Alzheimer’s diseaseespecially in people over 55 years.
The test, called Lumipulse gallows to detect the presence of two fundamental proteins: PTAU217 and β-amyloid 1-42biomarkers associated with the development of amyloid plaques, characteristics of this neurodegenerative disease.
The test is based on the measurement of these proteins in plasma samples obtained by blood analysis, which represents a less invasive alternative against traditional tests.
Until now, the detection of these biomarkers required the analysis of cerebrospinal fluid (CSF), obtained by lumbar puncture, an invasive and painful procedure.
According to the EFE agency, the accumulation of amyloids corresponds to anomalous protein deposits that alter neuronal connections, accelerating brain degeneration associated with Alzheimer’s.
Although these proteins may also be present in other neurological diseases, their combined presence is considered a distinctive sign of Alzheimer’s, according to Fujirebio.
This new test represents a significant advance, since it allows to detect the disease in initial stages without resorting to positron emission tomography (PET), a more expensive technique, of limited access and that exposes the patient to radiation.
The United States Food and Medicines Administration (FDA) approved the commercialization of Lumipulse gwhich marks an important step towards early diagnosis and preventive intervention in patients with Alzheimer’s suspicion.
The clinical study that supported its approval
The approval by the FDA was based on a clinical study conducted by Fujirebio, in which 499 blood samples of people with cognitive impairment were analyzed.
According to data disseminated by the EFE agency, the study revealed that 91.7% of participants with high levels of PTAU217 and β-amyloid 1-42 They also presented amyloid plaques, confirmed by PET or CSF tests.
In addition, the test reached a specificity of 97.3%, since it yielded negative results in cases where the other tests also ruled out the presence of proteins.
These results support the effectiveness of Lumipulse g As a diagnostic tool for the early detection of Alzheimer’s, with a high level of precision and minimal invasiveness.
The NIVLES of proteins high levels of PTAU217 and β-amyloid 1-42 can be an initial indicator of the Alzheimer’s condition (Free Press Photo: Shutterstock)