Owkin AI-Powered Cancer Testing Solutions Cleared in Europe

Rapid diagnostic solutions for breast and colorectal cancer from AI biotech Owkin have been granted approval for use across the pond, making them the first testing products to be cleared. The company, which has offices in Paris as well as New York City, will now offer these products to pathology labs, oncologists, and surgeons in the U.K., Germany, and France, with an eventual expansion to the U.S. on the cards.

The breast cancer test, RlapsRisk BC, leverages advanced AI to predict relapses following treatment. Oncologists can use the test to categorize patients as being viable for targeted therapies or not requiring chemotherapy. MSIntuit CRC, which pre-screens for the microsatellite instability (MSI) biomarker found in colorectal cancer tumors, lets pathologists hone in on patients showing MSI while ruling out microsatellite stable phenotypes. The most effective treatment vectors can be easily identified with this diagnostic solution.

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First-of-its-kind status is touted for the pair of tests; MSIntuit CRC is the first CE-IVD approved product identifying microsatellite stable patients, and RlapsRisk BC is the first to gain the same clearance for early breast cancer patient relapse. They also differ from commonly used molecular or PCR testing in their affordability and accelerated timeline for producing results.