US FDA approves first blood test to diagnose Alzheimer's disease
Currently, there's no cure for Alzheimer's, but medicines have been approved that slow the disease progression.The new blood test, developed by Fujirebio Diagnostics, works by measuring the ratio of the two specific proteins in the blood (amyloid and tau).
Alzheimer's disease is believed to occur due to the presence of two types of protein in the brain: amyloid plaques and tau plaques. ()
Until now, these plaques could only be identified through costly PET scans or invasive spinal fluid tests.The US Food and Drug Administration (FDA) announced the approval on Friday, marking what experts believe could be a turning point in how the disease is diagnosed and managed.advertisement"Alzheimer's disease impacts too many people, more than breast cancer and prostate cancer combined,' said FDA Commissioner Dr. Marty Makary.He added, 'Knowing that 10% of people aged 65 and older have Alzheimer's, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients.'EARLIER DETECTION MEANS BETTER TREATMENTThe new blood test is not a standalone diagnostic tool, it is approved for use in clinical settings for patients who are already showing signs of cognitive decline.But it promises a simpler and more accessible method to screen for the disease, which could allow doctors to confirm Alzheimer's earlier and begin treatment when it's most effective.There are currently two FDA-approved drugs, lecanemab and donanemab, that target the amyloid plaques associated with Alzheimer's. While not cures, these treatments have shown they can modestly slow the disease's progression, especially when started early. That makes timely diagnosis crucial.Neurologists and Alzheimer's advocates say the blood test could help reduce the time it takes to get patients into treatment."Today's clearance is an important step for Alzheimer's diagnosis. It makes the process easier and potentially more accessible for U.S. patients earlier in the disease," said Dr. Michelle Tarver of the FDA's Center for Devices and Radiological Health.advertisementRELIABLE AND LESS INVASIVEIn clinical studies, the blood test performed comparably to more traditional diagnostic tools like PET scans and spinal taps.In the study, the new blood test correctly showed signs of Alzheimer's in about 92 out of 100 people who really had it, and correctly showed no signs in about 97 out of 100 people who didn't have it.
In clinical studies, the blood test performed comparably to more traditional diagnostic tools like PET scans and spinal taps. ()
Only a small number of people, less than 1 in 5, got unclear results from the test.This means the blood test is quite accurate in finding out whether someone has the early brain changes linked to Alzheimer's, especially in people who are already showing memory problems, or not.However, the test should only be used in hospitals or clinics where specialists can check for memory issues, and it should always be used along with other health information from the patient, the FDA report warned.advertisementThe main risk of this test is that it could sometimes give wrong results, either saying someone has signs of Alzheimer's when they don't (false positive), or missing the disease when it's actually there (false negative).
The test should only be used in hospitals or clinics where specialists can check for memory issues. ()
Alzheimer's gradually erodes memory, decision-making ability, and eventually, independence.As the population ages, the number of people affected by the disease is projected to grow dramatically.This blood test could also help reduce the emotional and financial toll of delayed diagnosis, something many families experience when symptoms are mistaken for normal aging or are missed altogether.Although the test is not yet widely available, its FDA approval opens the door for broader adoption in hospitals and clinics across the country, say experts.Trending Reel
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