Artificial intelligence biotech company Owkin announced Friday that its rapid AI diagnostic solutions for breast and colorectal cancer have been approved for use in Europe.
The tests are the first approved diagnostics created by Oakin, which has offices in New York and Paris. One solution is RlapsRisk BC, which uses AI to predict whether a breast cancer patient will relapse after treatment. The test helps oncologists determine which patients would benefit from targeted therapies and which could avoid chemotherapy, according to a news release.
The other solution is MSIntuit CRC. It is an AI-powered digital pathology diagnostic solution that prescreens for the microsatellite instability (MSI) biomarker in colorectal cancer tumors. MSI is a defect in a cell’s ability to correct errors when DNA is copied. Owkin’s solution allows pathologists to exclude microsatellite-stable phenotypes and focus only on patients showing MSI. This will help clinicians determine earlier which treatment is most effective for patients.
Both tests are the first of their kind, it is claimed Michaël Auffret, Senior Vice President of Diagnostic Products and Regulatory Affairs at Owkin. RlapsRisk BC is the first CE-IVD-approved pathology-based digital AI diagnostic that predicts whether early breast cancer patients will relapse, while MSIntuit CRC is the first CE-IVD-approved solution that enables the identification of microsatellite-stable patients.
These tests differ from standard processes such as molecular testing or PCR testing because they are cheaper and give faster results. Labs running the tests receive the results internally and don’t need to send them out for analysis, Auffret said.
“You can process the data locally,” Auffret said. “As a result, the result from the device will be faster than any solutions we require to send to a central lab.”
The tests are sold to pathology labs, oncologists and surgeons, Auffret said. It is starting in France, Germany and the UK and will then expand to other locations including the US
He added that while the use of AI is becoming more common in healthcare, Owkin’s goal is not to replace the work done by pathologists, but to provide valuable information.
“It is our intention to do [the solutions] fully integrated into the clinical workflow,” he said. “They’re innovative, but we don’t want them to disrupt the workflow of pathologists and oncologists. We really want them to make the work of different specialists easier.”
Owkin has completed validation studies for each product that will be published soon, Auffret said, but declined to comment on the results.
A whole host of companies are using AI in the life sciences in everything from digital pathology to helping pharmaceutical companies develop better drugs, something that Owkin itself is doing this in its partnership with Sanofi. Another digital pathology company, Paige, has partnered with Janssen to develop and deploy an AI-based biomarker test for advanced bladder cancer in the clinical setting.
For Owkin, receiving CE-marking for the first time for its breast and colorectal cancer diagnostic products is remarkable.
“This is an important milestone,” Offret said.
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