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Raffaele Colombo highlights FDA Breakthrough Device Designation for Roche’s TROP2 diagnostic assay

Raffaele Colombo/LinkedIn

May 4, 2025, 03:18

Raffaele Colombo highlights FDA Breakthrough Device Designation for Roche’s TROP2 diagnostic assay

Raffaele Colombo, Associate Director of Medicinal Chemistry at Zymeworks, shared a post on X by Stephen V Liu, adding:

“Based on AstraZeneca’s QCS for TROP2,
Roche Diagnostics received FDA Breakthrough Device Designation (BDD) for the VENTANA TROP2 (EPR20043) RxDx assay!

Nice spotlight presentation at AACR25.”

Read more about Roche’s FDA Breakthrough Device Designation for AI-driven NSCLC diagnostic here.

Raffaele Colombo

Quoting Stephen V Liu‘s post:

“Dr. Marina Garassino at WCLC24 Presidential Plenary presents Normalized Membrane Ratio of TROP2 as a biomarker for datopotamab deruxtecan in TROPION-Lung01 (Dato-DXd vs docetaxel in previously treated NSCLC which previously showed PFS benefit with Dato-DXd.“

Stephen V Liu

Learn more about Raffaele Colombo and TROPION-Lung01 on OncoDaily.

AACR AACR25 AstraZeneca Breakthrough Device Designation cancer Dato-DXd datopotamab deruxtecan FDA Marina Garassino Medicine at Georgetown University NSCLC OncoDaily Oncology Roche Diagnostics Stephen V Liu TROP2 TROPION-Lung01 VENTANA TROP2 WCLC24 Zymeworks

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