Roche, Eli Lilly's Alzheimer's blood test gets FDA clearance

Live updates

1. 19d ago

   FDA clears Roche and Eli Lilly pTau217 Alzheimer's blood test

   The FDA cleared the Elecsys pTau217 blood test, developed by Roche and Eli Lilly, to identify amyloid pathology in adults with cognitive decline. Roche announced the approval on August 24. This single-biomarker tool provides a minimally invasive alternative for primary and specialty care providers to detect Alzheimer's signs earlier than previous methods. Labcorp and Quest Diagnostics intend to offer the test, which previously earned CE mark certification earlier this year.

   Why it matters

   Earlier diagnostic methods often required more invasive procedures to identify amyloid pathology. This test allows for broader screening in clinical settings. It targets a specific biomarker to streamline the identification of cognitive decline.

   What is confirmed

   • The FDA cleared the Elecsys pTau217 blood test developed by Roche and Eli Lilly.
   • The test detects amyloid pathology in adults experiencing cognitive decline.
   • Roche announced the FDA approval on August 24.
   • Labcorp and Quest Diagnostics plan to offer the test.
   • The test received CE mark certification earlier this year.
   • The tool uses a single-biomarker approach to detect signs of Alzheimer's.

   Still unconfirmed

   • The test is approved for Americans as young as 40.
   • The test is intended for people aged 55 and older.

   What to watch next

   • Confirmation of the specific age range for approved use
   • Clinical data on the test's accuracy compared to traditional methods
   Sources used for this update (4)

   1. www.yahoo.com — Roche, Eli Lilly get FDA nod for new Alzheimer’s blood test
   2. www.aha.org — FDA approves new Alzheimer’s blood test
   3. finance.yahoo.com — FDA Nods Lilly-Roche's Alzheimer's Blood Test: Healthcare ETFs to Track Now
   4. www.aol.com — FDA clears first single-biomarker blood test for Alzheimer’s: 4 experts weigh in
   confidence 95%
2. 21d ago

   FDA clears Roche and Eli Lilly blood test for Alzheimer's detection

   The US Food and Drug Administration cleared the Elecsys pTau217 blood test developed by Roche and Eli Lilly to help identify signs of Alzheimer's disease. The test is intended for use in primary and specialty care to detect amyloid pathology in adults with cognitive decline. While some reports specify the test is for people aged 55 and older, other sources state it is approved for Americans as young as 40. The minimally invasive tool allows physicians to identify symptoms of the disease earlier than previous methods.

   Why it matters

   Amyloid pathology is a primary characteristic of Alzheimer's disease. Traditional detection often requires more invasive procedures. This blood-based alternative simplifies the evaluation process for clinicians.

   What is confirmed

   • The FDA cleared the Alzheimer's blood test developed by Roche and Eli Lilly.
   • The test is called Elecsys pTau217.
   • The test helps physicians identify amyloid pathology in adults with cognitive decline.
   • The test is cleared for use in both primary and specialty care.

   Still unconfirmed

   • The test is approved for Americans as young as 40.
   • The test is specifically for people age 55 and older.

   What to watch next

   • Clinical data on the accuracy of the test across different age groups
   • Insurance coverage decisions for the Elecsys pTau217 test
   Sources used for this update (11)

   1. WSJ — FDA Approves Alzheimer’s Blood Test Developed by Roche and Eli Lilly
   2. WashU Medicine — FDA clears blood test to aid evaluation for Alzheimer’s disease
   3. Reuters — Roche, Eli Lilly's Alzheimer's blood test gets FDA clearance
   4. New Atlas — FDA approves first Alzheimer's blood test for Americans as young as 40
   5. qz.com — FDA clears Roche and Eli Lilly's Alzheimer's blood test for primary and specialty care
   6. The Washington Post — FDA approves a new blood test to detect signs of Alzheimer’s
   7. consent.yahoo.com — FDA clears Roche and Eli Lilly Alzheimer's blood test
   8. www.yahoo.com — Roche, Eli Lilly’s Alzheimer’s blood test gets FDA clearance
   9. www.straitstimes.com — Roche, Eli Lilly’s Alzheimer’s blood test gets US FDA clearance
   10. www.ibj.com — Alzheimer’s blood test developed by Roche, Lilly gets FDA clearance
   11. www.forbes.com — FDA Clears Roche And Eli Lilly’s Alzheimer’s Blood Test
   confidence 90%