By MATTHEW PERRONE
WASHINGTON (AP) — U.S. well being officers on Friday endorsed the primary blood take a look at that may assist diagnose Alzheimer’s and establish sufferers who might profit from medicine that may modestly gradual the memory-destroying illness.
The take a look at can support medical doctors in figuring out whether or not a affected person’s reminiscence issues are as a result of Alzheimer’s or a lot of different medical circumstances that may trigger cognitive difficulties. The Meals and Drug Administration cleared it for sufferers 55 and older who’re exhibiting early indicators of the illness.
Greater than 6 million individuals in the USA and thousands and thousands extra world wide have Alzheimer’s, the most typical type of dementia.
The brand new take a look at, from Fujirebio Diagnostics, Inc., identifies a sticky mind plaque, often called beta-amyloid, that could be a key marker for Alzheimer’s. Beforehand, the one FDA-approved strategies for detecting amyloid have been invasive checks of spinal fluid or costly PET scans.
The decrease prices and comfort of a blood take a look at might additionally assist broaden use of two new medicine, Leqembi and Kisunla, which have been proven to barely gradual the development of Alzheimer’s by clearing amyloid from the mind. Medical doctors are required to check sufferers for the plaque earlier than prescribing the medicine, which require common IV infusions.
“Today’s clearance is an important step for Alzheimer’s disease diagnosis, making it easier and potentially more accessible for U.S. patients earlier in the disease,” mentioned Dr. Michelle Tarver, of FDA’s heart for gadgets.
Quite a lot of specialty hospitals and laboratories have already developed their very own in-house checks for amyloid lately. However these checks aren’t reviewed by the FDA and usually aren’t lined by insurance coverage. Medical doctors have additionally had little knowledge to evaluate which checks are dependable and correct, resulting in an unregulated market that some have known as a “wild west.”
A number of bigger diagnostic and drug firms are additionally growing their very own checks for FDA approval, together with Roche, Eli Lilly and C2N Diagnostics.
The checks can solely be ordered by a physician and aren’t meant for individuals who don’t but have any signs.
AP Medical Author Lauran Neergaard contributed to this story
The Related Press Well being and Science Division receives help from the Howard Hughes Medical Institute’s Science and Academic Media Group. The AP is solely liable for all content material.
Initially Revealed: Could 16, 2025 at 4:33 PM EDT
