Sign in Subscribe
Diseases

FDA Clears First Blood Test for Alzheimer's Diagnosis

Strategic Insights

— 1 min read

U.S. health officials have 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. The test, developed by Fujirebio Diagnostics, Inc., identifies a sticky brain plaque, known as beta-amyloid, that is a key marker for Alzheimer's. This breakthrough has the potential to aid doctors in determining whether a patient's memory problems are due to Alzheimer's or other medical conditions.

Key Takeaways:

  • The FDA has cleared the first blood test for Alzheimer's diagnosis, developed by Fujirebio Diagnostics, Inc.
  • The test identifies beta-amyloid, a key marker for Alzheimer's, in patients 55 and older who are showing early signs of the disease.
  • The test can aid doctors in distinguishing Alzheimer's from other medical conditions that cause cognitive difficulties.
  • The new test has the potential to expand the use of two new drugs, Leqembi and Kisunla, which have been shown to slightly slow the progression of Alzheimer's.
  • Doctors are required to test patients for the plaque before prescribing the drugs, which require regular IV infusions.
  • Several larger diagnostic and drug companies, including Roche and Eli Lilly, are developing their own tests for FDA approval.
  • The test can only be ordered by a doctor and is not intended for people who don't yet have any symptoms.
  • The FDA requires doctors to test patients for the plaque before prescribing the drugs, which are only available for patients 55 and older.

Statistics:

  • More than 6 million people in the United States have Alzheimer's disease.
  • The new test can aid doctors in diagnosing Alzheimer's and identifying patients who may benefit from drugs that can modestly slow the disease.
  • The test has the potential to expand the use of two new drugs, Leqembi and Kisunla, which have been shown to slightly slow the progression of Alzheimer's.
  • The test can only be ordered by a doctor and is not intended for people who don't yet have any symptoms.

Sources:

  • [Matthew Perrone, Associated Press] "FDA clears first blood test for Alzheimer's diagnosis"
  • [Fujirebio Diagnostics, Inc.] "First Blood Test for Alzheimer's Diagnosis"
  • [The Associated Press] "Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science and Educational Media Group"

Read more