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Roche, Eli Lilly’s Alzheimer’s blood test gets U.S. FDA clearance

The test is intended for adults 55 and older with cognitive decline and is meant to improve access to less invasive Alzheimer’s evaluation.

  • On Monday, the U.S. Food and Drug Administration cleared the Elecsys pTau217 blood test from Roche and Eli Lilly to identify Alzheimer's-related brain changes in adults aged 55 and older with cognitive decline.
  • Previously, doctors relied on expensive, invasive PET scans or cerebrospinal fluid testing to detect Alzheimer's pathology, creating barriers for patients seeking early diagnosis of cognitive decline.
  • Roche and Lilly stated the test is "minimally invasive" and operates alongside "existing laboratory workflows," meaning clinics will not need to purchase additional equipment.
  • Both Labcorp and Quest Diagnostics plan to offer the test through their laboratory networks, potentially expanding access across the United States later this year.
  • Early diagnosis allows patients to begin treatments when they are most effective, positioning this clearance within a broader landscape of Alzheimer's tests including C2N Diagnostics' PrecivityAD2 for adults as young as 40.
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(Las Vegas = Yonhap News) Correspondent Kim Kyung-yoon = It is expected that Alzheimer's disease will be accurately diagnosed at local clinics through a simple blood test.

·Seoul, Korea (the Republic of)
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The Food and Drug Administration of the United States (FDA) approved a blood test to identify symptoms of Alzheimer's disease, developed jointly by Roche and Eli Lilly. Exclusive material for subscribers. To have full access, access the link of the material and register.

·Rio de Janeiro, Brazil
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New Atlas broke the news in Melbourne, Australia on Monday, August 24, 2026.
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