Washington – The United States health officials on Friday supported the first Blood analysis that can help diagnose Alzheimer’s and identify patients who can benefit from drugs That can modestly slow down the disease that destroys memory.
The test can help doctors determine whether a patient’s memory problems are due to Alzheimer’s or a series of other medical conditions that can cause cognitive difficulties. Food and medication administration eliminated it for patients of 55 years or more who show 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 way of dementia.
The new test, of Fujirebio Diagnostics, Inc., identifies a sticky brain plate, known as beta-amyloid, which is a key marker for Alzheimer’s. Previously, the only methods approved by the FDA to detect amyloid were invasive spinal fluid tests or expensive pets.
The lowest costs and convenience of a blood test could also help expand the use of two new medications, Leqembi and Kisunla, which has been shown to slightly slow down Alzheimer’s progression when cleaning the amyloid of the brain. Doctors are required to try patients for the plate before prescribing medications, which require regular IV infusions.
“Today’s authorization is an important step for the diagnosis of Alzheimer’s disease, which makes it easier and more accessible to US patients before the disease,” said Dr. Michelle Tarver, from the FDA devices center.
Several hospitals and specialized laboratories have already developed their own internal tests for amyloid in recent years. But these evidence are not reviewed by the FDA and are generally not covered by insurance. Doctors have also had few data to judge what tests are reliable and precise, which leads to an unregulated market that some have called a “Wild West”.
Several larger diagnostic and pharmaceutical companies are also developing their own tests for the approval of the FDA, including the diagnoses of Roche, Eli Lilly and C2N.
The tests can only be ordered by a doctor and are not intended for people who still have no symptoms.
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The AP medical writer, Lauran Dietgaard, contributed to this story
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