FDA OKs first blood test that can help diagnose Alzheimer's disease

WASHINGTON (AP) — U.S. wellness officials connected Friday endorsed the archetypal blood trial that tin assistance diagnose Alzheimer’s and place patients who whitethorn benefit from drugs that tin modestly dilatory the memory-destroying disease.

The trial tin assistance doctors successful determining whether a patient’s representation problems are owed to Alzheimer’s oregon a fig of different aesculapian conditions that tin origin cognitive difficulties. The Food and Drug Administration cleared it for patients 55 and older who are showing aboriginal signs of the disease.

More than 6 cardinal radical successful the United States and millions much astir the satellite person Alzheimer’s, the astir communal signifier of dementia.

The caller test, from Fujirebio Diagnostics, Inc., identifies a sticky encephalon plaque, known arsenic beta-amyloid, that is simply a cardinal marker for Alzheimer’s. Previously, the lone FDA-approved methods for detecting amyloid were invasive tests of spinal fluid oregon costly PET scans.

The little costs and convenience of a humor trial could besides assistance grow usage of 2 caller drugs, Leqembi and Kisunla, which person been shown to somewhat dilatory the progression of Alzheimer’s by clearing amyloid from the brain. Doctors are required to trial patients for the plaque earlier prescribing the drugs, which necessitate regular IV infusions.

“Today’s clearance is an important measurement for Alzheimer’s illness diagnosis, making it easier and perchance much accessible for U.S. patients earlier successful the disease,” said Dr. Michelle Tarver, of FDA’s halfway for devices.

A fig of specialty hospitals and laboratories person already developed their ain in-house tests for amyloid successful caller years. But those tests aren’t reviewed by the FDA and mostly aren’t covered by insurance. Doctors person besides had small information to justice which tests are reliable and accurate, starring to an unregulated marketplace that immoderate person called a “wild west.”

Several larger diagnostic and cause companies are besides processing their ain tests for FDA approval, including Roche, Eli Lilly and C2N Diagnostics.

The tests tin lone beryllium ordered by a doc and aren’t intended for radical who don’t yet person immoderate symptoms.

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AP Medical Writer Lauran Neergaard contributed to this story

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