Roche gets US green light for innovative Alzheimer’s test
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Roche gets US green light for innovative Alzheimer’s test
Swiss pharmaceutical firm Roche has received approval from the US Food and Drug Administration (FDA) for its Elecsys pTau181 test capable of diagnosing Alzheimer's and other cognitive disorders through blood samples.
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The test – developed by Roche in collaboration with the US pharmaceutical group Eli Lilly – is designed for patients aged 55 years and older with cognitive disorders or symptoms.
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Elecsys pTau181 measures the blood concentration of the phosphorylated tau protein (pTau181), which is often elevated in the presence of Alzheimer’s disease. In the case of non-significant values, the disease can be excluded with a high degree of probability.
The test can be performed in family doctors’ offices, simplifies the diagnosis of the disease and helps determine whether a patient’s cognitive decline is due to Alzheimer’s or not.
It also saves costs associated with more invasive examinations. Currently, a computed tomography scan or analysis of cerebrospinal fluid by puncturing the spinal cord is required to obtain a clear diagnosis.
For its test, Roche had already obtained the CE mark of conformity last July for marketing the product on the European Union market.
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Translated from Italian with DeepL/mga
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