Alzheimer's is diagnosed with a blood test

The American FDA, as reported by our national newspaper Today.it , has approved the first blood test for the early diagnosis of Alzheimer's. The test, developed by the American company Fujirebio Diagnostics, and called 'Lumipulse', identifies early amyloid plaques, a hallmark of the disease, detected until now only through brain scans or analysis of spinal fluid. "Alzheimer's disease affects too many people, more than breast cancer and prostate cancer combined," said the FDA commissioner, Martin A. Makary. "Considering that 10 percent of people aged 65 and over suffer from Alzheimer's, and that figure is expected to double by 2050, I hope that new medical products like this can help patients."

The approval of this test will help to more easily identify those patients who can be treated with the new anti-amyloid drugs that aim to reduce or remove amyloid plaques in the brain, and slow the progression of the disease by up to 35 percent, but only if administered in the early stages. Currently, only two of these drugs are available approved by the FDA: donanemab and lecanemab, approved in April by the EMA but only in one category of patients. These monoclonal antibodies, if administered in the early stages of the disease, can offer patients a few more months of independence.

How the test works

The test, called Lumipulse G pTau217/ß-amyloid 1-42 , measures two proteins present in human plasma, pTau217 and β-amyloid 1-42, associated with the accumulation of amyloid plaques and tau tangles in the brain. If the levels of these proteins are elevated, it means that a process of neurodegeneration is underway. Studies have in fact shown that the accumulation of the beta-amyloid protein in the cerebrospinal fluid is evident already between 18 and 14 years before diagnosis .

The test, approved for clinical use in patients over 55, has been shown to be as effective (90 percent) in detecting signs of Alzheimer's as cerebrospinal fluid tests and positron emission tomography (PET) scans, which look for beta-amyloid plaques in the brain.

A breakthrough in early diagnosis

Requiring only a simple blood draw, this test offers a less invasive option that is much easier for patients to perform than traditional methods, although its results must be interpreted in conjunction with other clinical information about the patient. "Today's authorization is an important step for Alzheimer's diagnosis, making it easier and potentially more accessible for patients in the early stages of the disease," said Dr. Michelle Tarver, Director of the Center for Devices and Radiological Health. "Nearly 7 million Americans are living with Alzheimer's disease, and that number is expected to rise to nearly 13 million. The authorization of this test is an important step for Alzheimer's diagnosis, making it easier and potentially more accessible for patients in the early stages of the disease."