The U.S. Food and Drug Administration (FDA) has cleared another blood test designed to help doctors evaluate Alzheimer’s disease and other causes of memory and cognitive decline. The approval marks an important step toward quicker and less invasive diagnosis of the condition.Roche Diagnostics announced on Monday that the FDA has authorized its Alzheimer’s blood test, developed in partnership with Eli Lilly. The new test aims to assist doctors in the early assessment of patients who may be showing signs of dementia. This approval comes soon after the FDA gave the green light to Fujirebio Diagnostics’ Lumipulse test in May 2025, the first blood test ever approved to identify the degenerative brain condition.As this new test gains attention, here’s a closer look at how it works, what sets it apart, and what other blood tests have been approved for Alzheimer’s diagnosis.Lilly’s Test Approved for Alzheimer’s DiagnosisRoche Diagnostics confirmed that the FDA has granted clearance for Elecsys, its blood test co-developed with Eli Lilly, as a tool to help assess Alzheimer’s disease. The test measures pTau181, a protein strongly linked to Alzheimer’s and brain degeneration. It is designed for people aged 55 and older who are showing signs or symptoms of cognitive decline.This approval follows the earlier FDA authorization of ‘Fujirebio’s Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio’ test in May. Together, these tests represent major progress in early detection, which could make it easier for patients to begin treatment with drugs such as Biogen and Eisai’s Leqembi or Eli Lilly’s Kisunla. Traditional diagnostic options, such as spinal taps or PET brain scans, are either invasive or costly and not always covered by insurance.As per CNN, Roche reported that in a clinical trial involving 312 people, Elecsys demonstrated a 97.9% success rate in ruling out Alzheimer’s. The company also highlighted that over 4,500 diagnostic machines are already operating in U.S. laboratories, making it easier to integrate this new test into existing systems.What Is the Elecsys pTau181 Test?The Elecsys pTau181 test is now the second blood-based biomarker test cleared by the FDA this year for Alzheimer’s diagnosis. Unlike the Lumipulse test, which measures a ratio of two proteins (pTau217 and beta-amyloid 1-42), Elecsys focuses on detecting the levels of a single protein—pTau181—in a person’s blood plasma. Elevated levels of this protein are often associated with Alzheimer’s and other neurodegenerative disorders.Although several laboratory-developed and experimental tests are under study, blood-based testing remains an emerging yet promising tool in dementia research.“The ability to diagnose Alzheimer’s earlier with a simple blood test—similar to how we test for cholesterol—is a real breakthrough,” said Dr. Howard Fillit, co-founder and chief science officer of the Alzheimer’s Drug Discovery Foundation. He explained that such advancements can help identify the disease sooner, giving patients better access to treatments that might slow or even prevent its progression.With Roche’s Elecsys test now approved, experts like Dr. Richard Isaacson say the development is encouraging. Still, they advise cautious optimism as scientists continue refining blood-based diagnostics for Alzheimer’s.
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