Two Owkin Diagnostics Products Received CE-IVD Mark

Two diagnostics products from Owkin, the Owkin Dx RlapsRisk BC and the Owkin Dx MSIntuit CRC, have received the CE-IVD mark.

The RlapsRisk BC is an artificial intelligence (AI) diagnostic that predicts the risk that early breast cancer patients will relapse.

The MSIntuit CRC, which also includes AI technology, is used in the area of colorectal cancer and enables the identification of microsatellite stable (MSS) patients from routine histology slides, allowing a significant reduction in time and the number of diagnostic tests for detecting the biomarker microsatellite instability.

These approvals are the first for the company’s diagnostics products. Owkin said it intends to develop more biomarker prescreening and outcome prediction diagnostics across a range of disease areas.