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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