Roche has partnered with PathAI to leverage artificial intelligence (AI) to develop algorithms for companion diagnostics.

PathAI will exclusively work with Roche Tissue Diagnostics (RTD) for an undisclosed pre-specified time to develop AI-enabled digital pathology algorithms in the companion diagnostics space. The companies were quick to add that PathAI will retain the ability to continue to develop its algorithms for companion diagnostics aside from the Roche deal.

The US Food and Drug Administration (FDA) defines a companion diagnostic test as a medical device, often an in vitro device, which provides information that is essential for the safe and effective use of a corresponding drug or biological product.

GlobalData market analysis expects oncology indications to have a thriving test market that will be valued at over $3.1bn in 2030. The rapid growth will be driven by the quick adoption rate of companion diagnostic tests.

Multiple companies are developing companion diagnostics for oncology indications. In November 2023, Foundation Medicine partnered with Pierre Fabre Laboratories to develop FoundationOne CDx and FoundationOneLiquid CDx genomic tests as companion diagnostics for new targeted therapies to treat NSCLC patients. The tests will be used to detect patients with specific mutations that can be treated with Pierre Fabre and Pfizer’s BRAF/MEK inhibitor combination regimen, Braftovi (encorafenib) and Mektovi (binimetinib).

Roche plans to deploy the algorithms developed under the agreement to its navify digital pathology solution. Current algorithms will add to PathAI’s image analysis algorithms developed and deployed as part of a previous partnership between the companies.

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Roche has invested in developing and deploying AI-assisted diagnostics as part of its navify platform. In October 2023, the company partnered with Ibex Medical Analytics and Amazon Web Services to enable pathology laboratories to access Ibex’s AI-powered decision support tools to aid in the diagnosis of breast and prostate cancer. Ibex’s CE-marked AI algorithms would integrate with the navify platform to display information to help clinicians in diagnosing breast and prostate biopsies.