FILE - R. Scott Turner, Professor of Neurology and Director of the Memory Disorder Center at Georgetown University Hospital, points to PET scan results that are part of a study on Alzheimer’s disease at Georgetown University Hospital in Washington, May 19, 2015. (AP Photo/Evan Vucci, File)
FDA OKs first blood test that can help diagnose Alzheimer’s disease
WASHINGTON (AP) 鈥 U.S. health officials on Friday endorsed the first blood test that can help diagnose Alzheimer鈥檚 and identify patients who may benefit from drugs that can modestly slow the memory-destroying disease.
FILE - R. Scott Turner, Professor of Neurology and Director of the Memory Disorder Center at Georgetown University Hospital, points to PET scan results that are part of a study on Alzheimer’s disease at Georgetown University Hospital in Washington, May 19, 2015. (AP Photo/Evan Vucci, File)
WASHINGTON (AP) 鈥 U.S. health officials on Friday endorsed the first blood test that can help diagnose Alzheimer鈥檚 and identify patients who may benefit from drugs that can modestly slow the memory-destroying disease.
The test can aid doctors in determining whether a patient鈥檚 memory problems are due to Alzheimer鈥檚 or a number of other medical conditions that can cause cognitive difficulties. The Food and Drug Administration cleared it for patients 55 and older who are showing early signs of the disease.
More than 6 million people in the United States and millions more around the world have Alzheimer鈥檚, the most common form of dementia.
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The new test, from Fujirebio Diagnostics, Inc., identifies a sticky brain plaque, known as beta-amyloid, that is a key marker for Alzheimer鈥檚. Previously, the only FDA-approved methods for detecting amyloid were invasive tests of spinal fluid or expensive PET scans.
The lower costs and convenience of a blood test could also help expand use of two new drugs, Leqembi and Kisunla, which have been shown to slightly slow the progression of Alzheimer鈥檚 by clearing amyloid from the brain. Doctors are required to test patients for the plaque before prescribing the drugs, which require regular IV infusions.
鈥淭oday鈥檚 clearance is an important step for Alzheimer鈥檚 disease diagnosis, making it easier and potentially more accessible for U.S. patients earlier in the disease,鈥 said Dr. Michelle Tarver, of FDA鈥檚 center for devices.
A number of specialty hospitals and laboratories have already developed their own in-house tests for amyloid in recent years. But those tests aren鈥檛 reviewed by the FDA and generally aren鈥檛 covered by insurance. Doctors have also had little data to judge which tests are reliable and accurate, leading to an unregulated marketplace that some have called a 鈥渨ild west.鈥
Several larger diagnostic and drug companies are also developing their own tests for FDA approval, including Roche, Eli Lilly and C2N Diagnostics.
The tests can only be ordered by a doctor and aren鈥檛 intended for people who don鈥檛 yet have any symptoms.
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AP Medical Writer Lauran Neergaard contributed to this story
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute鈥檚 Science and Educational Media Group. The AP is solely responsible for all content.
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