An AI-Driven Companion Diagnostic Receives FDA Designation in NSCLC

The Ventana TROP2 (EPR20043) RxDx Device, a computational pathology companion diagnostic (CDx), was granted breakthrough device designation by the U.S. Food and Drug Administration (FDA) for patients with non–small cell lung cancer, making it the first computational pathology CDx device to receive this designation.

The announcement from the regulatory agency was shared in a news release from Roche Diagnostics, which went on to note that the Ventana TROP2 RxDx Device is an immunohistochemistry assay which is combined with a digital pathology algorithm to determine treatment for patients. Moreover, because the device uses artificial intelligence-based image analysis, this exceeds the level of diagnostic precision that is possible with traditional manual scoring methods.

Breakthrough device designation from the FDA means that the agency will commit more resources to review the device on an accelerated timeline, according to the National Institute of Health website. A device is granted breakthrough device designation when it meets criteria set forth by the FDA, according to their official website. This criterion includes showing preliminary clinical evidence that the device may have substantial impact for patients within the space.

“This FDA breakthrough device designation is another example of our commitment to deliver innovation that enables more precise diagnosis in oncology,” Matt Sause, CEO of Roche Diagnostics, stated in the news release. “This solution, which leverages our industry-leading expertise in companion diagnostics development, uses artificial intelligence for a greater depth of sample analysis, helping to deliver truly personalized treatment.”

Because it has now been granted breakthrough device designation by the FDA, the news release states that the Ventana TROP2 RxDx Device may become available for patients sooner. This is important because it may aid in the identification of patients with non–small cell lung cancer who are most likely to benefit from treatment with Datroway (datopotamab deruxtecan-dlnk).

Datroway is a specifically engineered TROP2-directed antibody drug conjugate. Antibody drug conjugates are a kind of therapeutic which works by combining targeted therapy and chemotherapy, according to the Cleveland Clinic website. The site goes on to say that these therapeutic agents are used when cancers come back, spread or when other treatments aren’t effective. Antibody drug conjugates have the ability to damage cancerous cells without harming nearby healthy cells by delivering powerful chemotherapy drugs to specific cells.

More Information on the AI-Driven Companion Diagnostic, the Ventana TROP2 RxDx Device

The Ventana TROP2 RxDx Device is a computational pathology device — a diagnostic system — that can analyze digital pathology images of stained tissue slides with Roche Digital Pathology scanners, as well as manage and store these digital slide images. The device is able to assess stained tissue slides through TROP2 IHC staining.

“The algorithm incorporates AstraZeneca’s proprietary computational pathology platform, Quantitative Continuous Scoring, which enables a level of diagnostic precision not possible with traditional manual scoring methods,” the news release writes.

Overall, the use of this device should ideally enable healthcare professionals to more accurately identify patients with previously treated advanced or metastatic non-squamous non–small cell lung cancer without actionable genomic alterations who are most likely to benefit from treatment with Datroway. Pathologists are still intended to review the images and ensure adequate tumor detection sensitivity and precision with the use of histological examination, relevant clinical information, and proper controls in addition to use of the device.

“This FDA breakthrough device designation underscores the potential of our computational pathology platform to enable more personalized treatment decisions for people with cancer,” said Susan Galbraith, executive vice president of Oncology Hematology R&D, at AstraZeneca.

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