Roche Holding AG (RHHBY) Tuesday said that the U.S. Food and Drug Administration (FDA) has granted breakthrough device designation for the VENTANA TROP2 RxDx Device.
VENTANA TROP2 RxDx Device is a computational pathology device indicated as an aid in identifying patients with previously treated advanced or metastatic non-squamous NSCLC without actionable genomic alteration (AGA).
The FDA granting Breakthrough Device Designation has the potential to make a TROP2 CDx AI-driven system available sooner, which could aid in identifying patients with NSCLC most likely to benefit from treatment with Daiichi Sankyo and AstraZeneca's DATROWAY, the company said in a statement.
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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.