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Aakash Desai: Roche received Breakthrough Device Designation from the FDA for the VENTANA TROP2 RxDx Device

roche.com

Apr 30, 2025, 07:43

Aakash Desai: Roche received Breakthrough Device Designation from the FDA for the VENTANA TROP2 RxDx Device

Aakash Desai, Associate Director of Phase 1 and Precision Oncology Program at UAB O’Neal Comprehensive Cancer Center, shared a post on LinkedIn:

“Exciting news in precision oncology:

Roche has received Breakthrough Device Designation from the FDA for the VENTANA TROP2 (EPR20043) RxDx Device—the first AI-powered companion diagnostic in non-small cell lung cancer (NSCLC).

What makes it groundbreaking:

Combines AI-driven image analysis with digital pathology.
Offers a new level of diagnostic precision beyond manual methods.
Enables more tailored treatment decisions in NSCLC.

This milestone underscores the power of AI + diagnostics to transform cancer care by delivering more personalized, and efficient solutions. How can we scale and make this more clinically applicable is the next?”

Aakash Desai: Roche received Breakthrough Device Designation from the FDA for the VENTANA TROP2 RxDx Device

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