FDA Approves Alzheimer’s Blood Test Developed by Roche and Eli Lilly

Live updates

1. 20d ago

   FDA Approves Roche and Eli Lilly Alzheimer's Blood Test

   The FDA approved a biomarker blood test developed by Roche and Eli Lilly to detect Alzheimer's disease, according to a Roche announcement on August 24. The test is authorized for use in primary and specialty care settings. Labcorp and Quest Diagnostics plan to offer the test, which previously received CE mark certification. While some reports suggest the test is for patients 55 and older, other data indicates it is authorized for Americans as young as 40. The test offers a less invasive alternative to previous diagnostic standards for identifying disease biomarkers.

   Why it matters

   Early detection of Alzheimer's biomarkers allows for faster diagnosis and potential intervention. Shifting these tests into primary care reduces the reliance on more invasive diagnostic procedures. This approval follows the test's earlier certification in European markets.

   What is confirmed

   • The FDA approved an Alzheimer's biomarker blood test developed by Roche and Eli Lilly.
   • Roche announced the FDA approval on August 24.
   • Labcorp and Quest Diagnostics plan to provide the test.
   • The test received CE mark certification earlier this year.
   • The test is authorized for use in both primary and specialty care settings.

   Still unconfirmed

   • The test is specifically for patients 55 and older.
   • The test is authorized for Americans as young as 40 years old.
   • The test has no disclosed price and no Health Canada status.

   What to watch next

   • Disclosure of the test's retail price
   • Confirmation of the minimum age requirement for authorized use
   • Updates on Health Canada approval status
   Sources used for this update (6)

   1. pharmaphorum.com — FDA greenlights Roche’s biomarker blood test for Alzheimer's
   2. www.yahoo.com — Roche, Eli Lilly get FDA nod for new Alzheimer’s blood test
   3. www.aha.org — FDA approves new Alzheimer’s blood test
   4. www.benefitsandpensionsmonitor.com — FDA clears blood test to flag Alzheimer's in patients 55 and older
   5. uk.finance.yahoo.com — Eli Lilly Clears Big Hurdle in Alzheimer's Fight
   6. finance.yahoo.com — Eli Lilly Clears Big Hurdle in Alzheimer's Fight
   confidence 90%
2. 22d ago

   FDA Approves Roche and Eli Lilly Alzheimer's Blood Test

   The FDA has cleared a blood test developed by Roche and Eli Lilly to assist in the evaluation of Alzheimer's disease. This biomarker test is available for use in both primary and specialty care settings. It is the first of its kind to receive approval and is authorized for use in Americans as young as 40 years old. The test provides a less invasive method for detecting biomarkers associated with the disease compared to previous diagnostic standards.

   Why it matters

   Traditionally, confirming Alzheimer's required more invasive procedures or expensive imaging. A blood-based biomarker test allows for earlier and easier screening. This shift helps clinicians identify patients who may benefit from early intervention.

   What is confirmed

   • The FDA cleared an Alzheimer's blood test developed by Roche and Eli Lilly.
   • The test is authorized for use in primary and specialty care.
   • The test is available for Americans as young as 40.

   What to watch next

   • Clinical adoption rates in primary care offices
   • Insurance coverage decisions for the biomarker test
   Sources used for this update (10)

   1. WSJ — FDA Approves Alzheimer’s Blood Test Developed by Roche and Eli Lilly
   2. Forbes — FDA Clears Roche And Eli Lilly’s Alzheimer’s Blood Test
   3. Yahoo Finance — Roche and Eli Lilly Win FDA Clearance for Alzheimer’s Blood Test
   4. 93.3 The Drive — Roche, Eli Lilly’s Alzheimer’s blood test gets FDA clearance
   5. marketscreener.com — FDA green lights Roche and Eli Lilly test in Alzheimer's disease
   6. WashU Medicine — FDA clears blood test to aid evaluation for Alzheimer’s disease
   7. Fierce Biotech — Roche, Eli Lilly net FDA approval for first-of-its-kind Alzheimer’s biomarker blood test
   8. New Atlas — FDA approves first Alzheimer's blood test for Americans as young as 40
   9. qz.com — FDA clears Roche and Eli Lilly's Alzheimer's blood test for primary and specialty care
   10. consent.yahoo.com — FDA clears Roche and Eli Lilly Alzheimer's blood test
   confidence 100%