On Friday, U.S. health authorities approved the first blood test capable of diagnosing Alzheimer’s disease.

This breakthrough may enable patients to start medication sooner, potentially slowing the progression of this degenerative neurological condition.

The test, developed by Fujirebio Diagnostics, measures the levels of two specific proteins in the blood.

These levels are linked to the presence of beta-amyloid plaques in the brain, a hallmark of Alzheimer’s disease.

Previously, these plaques could only be detected through cerebral imaging or analysis of cerebrospinal fluid.

Marty Makary from the Food and Drug Administration noted that "Alzheimer’s affects a vast number of people, surpassing the combined cases of breast and prostate cancer.

" He added that "10% of individuals aged 65 and older are diagnosed with Alzheimer’s, and this number is expected to double by 2050," expressing hope that new medical products like this test will assist them.

Currently, there are two FDA-approved medications for Alzheimer’s, namely lecanemab and donanemab. These drugs target amyloid plaques and can moderately slow cognitive decline but do not cure the disease.

Proponents of these medications, including neurologists, believe that they can provide patients with additional months of independence, particularly if administered early in the disease’s progression.

Clinical trial results for the blood test have shown a high level of accuracy, comparable to brain imaging scans using positron emission tomography (PET) and cerebrospinal fluid analysis.

Michelle Tarver from the FDA's Center for Devices and Radiological Health remarked that the approval of this new test represents a significant milestone in Alzheimer’s diagnosis, making it easier and more accessible for patients in the United States at the early stages of the disease.

The test is now approved for use in patients exhibiting signs of cognitive decline, with the interpretation of results taking into account other clinical information.

Alzheimer’s disease is the most common form of dementia, gradually deteriorating the patient’s memory and independence over time.

First Blood Test Approved for Alzheimer’s Diagnosis in the U.S

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