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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Business News
June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.