FDA Approves Roche’s VENTANA® TROP2 RxDx Breakthrough Device for Personalized Treatment

Roche has announced that the U.S FDA has granted Breakthrough Device Designation for its VENTANA® TROP2 (EPR20043) RxDx Device. The designation highlights the innovative approach of the VENTANA TROP2 device, which integrates artificial intelligence (AI) to support more accurate and individualised diagnosis in oncology. It aims to improve personalised treatment decisions by offering deeper analysis of tissue samples.

The VENTANA TROP2 (EPR20043) RxDx Device includes several components: the TROP2 algorithm, navify® Digital Pathology Image Management System, Roche Digital Pathology scanners (DP 200 and DP 600), and the TROP2 assay used with the OptiView DAB Detection Kit. These are used on the BenchMark ULTRA IHC/ISH staining instrument to analyse whole slide images of non-small cell lung cancer (NSCLC) tissues stained for TROP2. 

The FDA's decision may accelerate the availability of this AI-powered CDx system, which could assist in identifying patients with NSCLC who are more likely to benefit from treatment with DATROWAY® (datopotamab deruxtecan-dlnk).
 
The VENTANA TROP2 (EPR20043) RxDx Device is used for the identification of patients with previously treated advanced or metastatic non-squamous NSCLC without actionable genomic alterations. Final diagnosis and assessment remain under the responsibility of a qualified pathologist, who reviews staining quality and tumour detection in combination with clinical data and appropriate controls.

Once the pathologist completes the assessment, the device’s nDP TROP2 algorithm autonomously identifies tumour cells and measures TROP2 staining intensity in both membrane and cytoplasm. It then calculates a Normalised Membrane Ratio (NMR) score and classifies the TROP2 status as either positive or negative based on a set threshold.