FDA Approval of Blood Test for Alzheimer’s Disease
The U.S. Food and Drug Administration (FDA) has endorsed the first blood test that can help diagnose Alzheimer’s disease and identify patients who may benefit from drugs that can modestly slow the progression of the disease. This breakthrough is expected to aid doctors in determining whether a patient’s memory problems are due to Alzheimer’s or other medical conditions that can cause cognitive difficulties.
What the Test Entails
The test, developed by Fujirebio Diagnostics, Inc., identifies a sticky brain plaque known as beta-amyloid, which is a key marker for Alzheimer’s. Previously, the only FDA-approved methods for detecting amyloid were invasive tests of spinal fluid or expensive PET scans. The new blood test offers a less invasive and more cost-effective alternative.
Benefits of the Test
More than 6 million people in the United States and millions more around the world have Alzheimer’s, the most common form of dementia. The lower costs and convenience of a blood test could also help expand the use of two new drugs, Leqembi and Kisunla, which have been shown to slightly slow the progression of Alzheimer’s by clearing amyloid from the brain. Doctors are required to test patients for the plaque before prescribing these drugs, which require regular IV infusions.
Impact on Diagnosis and Treatment
"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," said Dr. Michelle Tarver, of FDA’s center for devices. A number of specialty hospitals and laboratories have already developed their own in-house tests for amyloid in recent years. However, those tests aren’t reviewed by the FDA and generally aren’t covered by insurance.
Development of Similar Tests
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’t intended for people who don’t yet have any symptoms.
By MATTHEW PERRONE
WASHINGTON (AP) — U.S. health officials on Friday endorsed the first blood test that can help diagnose Alzheimer’s and identify patients who may benefit from drugs that can modestly slow the memory-destroying disease.
Related Articles
- Gene editing helped a desperately ill baby thrive. Scientists say it could someday treat millions
- DeSantis signs a bill making Florida the 2nd state to ban fluoride from its water system
- FACT FOCUS: Trump blames other countries for high US drug prices. Experts say it’s not their fault
- Risks of psychedelic use aren’t widely known. This campaign hopes to change that
- As LA County continues shutting down oil drilling rigs, supervisors seek info on health and safety
The test can aid doctors in determining whether a patient’s memory problems are due to Alzheimer’s 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’s, the most common form of dementia.
The new test, from Fujirebio Diagnostics, Inc., identifies a sticky brain plaque, known as beta-amyloid, that is a key marker for Alzheimer’s. 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’s by clearing amyloid from the brain. Doctors are required to test patients for the plaque before prescribing the drugs, which require regular 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,” said Dr. Michelle Tarver, of FDA’s 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’t reviewed by the FDA and generally aren’t 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 “wild west.”
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’t intended for people who don’t yet have any symptoms.
AP Medical Writer Lauran Neergaard contributed to this story
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.
Conclusion
The FDA approval of the first blood test for Alzheimer’s disease is a significant breakthrough in the diagnosis and treatment of the disease. The test offers a less invasive and more cost-effective alternative to existing methods, and its convenience could help expand the use of new drugs that can slow the progression of the disease.
FAQs
- What is the new blood test for Alzheimer’s disease?
The new blood test, developed by Fujirebio Diagnostics, Inc., identifies a sticky brain plaque known as beta-amyloid, which is a key marker for Alzheimer’s. - How does the test work?
The test detects the presence of beta-amyloid in the blood, which is a key indicator of Alzheimer’s disease. - What are the benefits of the test?
The test offers a less invasive and more cost-effective alternative to existing methods, and its convenience could help expand the use of new drugs that can slow the progression of the disease. - Who is the test intended for?
The test is intended for patients 55 and older who are showing early signs of Alzheimer’s disease. - Can the test be ordered by anyone?
No, the test can only be ordered by a doctor and isn’t intended for people who don’t yet have any symptoms.
