By Matthew Perrone
Washington (AP) – US health officials approved the first blood test on Friday that can help diagnose Alzheimer’s disease and identify patients who can benefit from drugs that can modestly slow down memory destructive disease.
The test can help doctors determine if a patient’s memory problems are due to Alzheimer’s disease or to a number of other medical conditions that can cause cognitive difficulties. The Food and Drug Administration has erased it for patients 55 and over who have early signs of the disease.
In the United States, more than 6 million people and millions of people worldwide have Alzheimer’s disease, the most common form of dementia.
The new test, by Fujirebio Diagnostics, Inc., identifies a sticky brain plate, known as beta-amyloid, which is a key marker for Alzheimer. Previously, the only methods approved by the FDA to detect the amyloid were invasive tests of spinal liquid or expensive TEP scanners.
Lowering costs and the convenience of a blood test could also help extend the use of two new drugs, Leqembi and Kisunla, which turned out to be slightly slowing down the progression of Alzheimer by clearing the amyloid from the brain. Doctors must test patients for the plaque before prescribing drugs, which require ordinary IV infusions.
“Today’s authorization is an important step for the diagnosis of Alzheimer’s disease, which makes it easier and potentially more accessible for American patients earlier in the disease,” said Dr. Michelle Tarver, the center for FDA devices.
A certain number of hospitals and specialized laboratories have already developed their own internal tests for the amyloid in recent years. But these tests are not examined by the FDA and are generally not covered by insurance. Doctors also had little data to judge which tests are reliable and precise, leading to an unregulated market that some have called a “far west”.
Several large diagnostic and pharmaceutical companies also develop their own tests for FDA approval, including Roche, Eli Lilly and C2N Diagnostics.
The tests can only be ordered by a doctor and are not intended for people who do not yet have symptoms.
The medical writer AP Lauran Neergaard contributed to this story
The Department of Health and Sciences of the Associated Press receives the support of the scientific and educational media group from Howard Hughes Medical Institute. The AP is solely responsible for all content.
Originally published:
California Daily Newspapers
