Topline
The U.S. Food and Drug Administration has granted clearance to a new blood test developed by Roche and Eli Lilly that aids in detecting Alzheimer’s-related indicators in individuals aged 55 and older, according to a Monday announcement from Roche.
The FDA cleared the new blood test on Monday, Roche and Eli Lilly said in a statement.
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Key Facts
The FDA has cleared the Elecsys Phospho-Tau (217P) Plasma blood test, which Roche and Eli Lilly describe as a single‑biomarker assay intended to assess the likelihood of amyloid pathology—a brain change associated with Alzheimer’s disease.
Previously, clinicians relied on PET scans or cerebrospinal fluid analysis—both costly and invasive—to detect amyloid pathology. Roche and Lilly note that the new test is minimally invasive, integrates seamlessly with existing laboratory workflows, and does not necessitate additional equipment purchases.
However, the assay is not intended to serve as a standalone diagnostic for Alzheimer’s and should be used alongside other clinical data.
Both Labcorp and Quest Diagnostics, major providers of blood‑testing services, have indicated they will begin offering the new assay.
