Roche (RHHBY) said that its Elecsys pTau217 assay received Breakthrough Device Designation from the U.S. Food and Drug Administration.
The Elecsys pTau217 plasma biomarker test is being developed as part of an ongoing partnership between Roche and Eli Lilly and Company.
Once approved, the test will aid healthcare providers in identifying amyloid pathology, a key feature of Alzheimer's disease, Roche said.
Roche and Lilly believe the test could play an important role in improving access to early and accurate Alzheimer's diagnosis.
Roche noted that pTau217, which is a phosphorylated fragment of the protein tau, is a biomarker that has shown the ability in research settings to distinguish Alzheimer's disease from other neurodegenerative disorders and has shown strong performance relative to other biomarkers.
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April 17, 2026 15:29 ET The ongoing conflict in the Middle East continues to raise concerns for policymakers who worry about the impact of the supply shock and high energy prices on the real economy. Producer price data and various survey results on the housing market were the main news from the U.S. this week. In Europe, industrial production data for the euro area gained attention. GDP figures out of China and the policy move by the Singapore central bank were in focus in Asia.