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The US Food and Drug Administration (FDA) has granted breakthrough device designation to Roche's computational pathology companion diagnostic (CDx) VENTANA TROP2 (EPR20043) RxDx device.
Roche noted that this immunohistochemistry (IHC) assay is the first AI-driven companion diagnostic intended for use in determining non-small cell lung cancer (NSCLC).
The VENTANA TROP2 device aims to help identify NSCLC subjects who are likely to benefit from Daiichi Sankyo and AstraZeneca’s Trop2-directed antibody drug conjugate, Datroway’s (datopotamab deruxtecan-dlnk) treatment.
It is specifically indicated for patients with advanced or metastatic non-squamous NSCLC without actionable genomic alterations.
The device comprises the TROP2 algorithm, Roche digital pathology scanners, navify Digital Pathology Image Management System, and the VENTANA TROP2 RxDx Assay, which is designed to work with the OptiView DAB Detection Kit to facilitate staining processes on the BenchMark ULTRA IHC/in situ hybridisation (ISH) staining instrument.
It is designed to deliver a quantitative trophoblast cell surface antigen 2 (Trop2) score by analysing whole slide images of NSCLC tissue, which are stained with TROP2.
Roche noted that incorporating AstraZeneca's Quantitative Continuous Scoring (QCS) platform, the algorithm achieves a level of diagnostic precision beyond traditional manual scoring methods.
The breakthrough device status by the FDA will expedite the availability of the TROP2 CDx system.
According to the company, a qualified pathologist plays a crucial role in reviewing staining and image quality, ensuring tumour detection sensitivity and precision.
Following this assessment, the nDP TROP2 algorithm identifies tumour cells independently and calculates the normalised membrane ratio (NMR) score, classifying the TROP2 status as positive or negative based on a predefined cutoff.
Roche Diagnostics CEO Matt Sause said: “This FDA breakthrough device designation is another example of our commitment to deliver innovation that enables more precise diagnosis in oncology.
“This solution, which leverages our industry-leading expertise in companion diagnostics development, uses AI for a greater depth of sample analysis, helping to deliver truly personalised treatment.”
Earlier this year, the company secured FDA 510(k) clearance for its Tina-quant Lipoprotein (a) Gen.2 Molarity assay.
"FDA grants breakthrough status to Roche’s VENTANA TROP2 device" was originally created and published by Medical Device Network, a GlobalData owned brand.