OWKIN presents two AI-based diagnostic solutions that have received CE-IVD certification

Owkin, a Franco-American start-up specializing in AI and federated learning applied to medical research, announced on September 2 that two of its diagnostic solutions, namely Owkin Dx RlapsRisk BC and Owkin Dx MSIntuit CRC, have received CE-IVD certification (CE Marking for In Vitro Diagnostics), which will enable it to market these solutions in Europe and thus improve the treatment of patients there suffering from breast or colorectal cancer.

Co-founded in 2016 by Thomas Clozel, clinical researcher and former assistant professor in clinical hematology, and Gilles Wainrib, doctor in AI applied to biology, Owkin is based in the United States, but the majority of its team is based in Paris. She is on a mission to use AI to discover and develop better treatments for unmet medical needs, starting with the fight against cancer.

Meriem Sefta, Director of Diagnostics at Owkin, says:

“Our mission is to use AI to find the right treatment for each patient. New drugs allow us to personalize treatments based on individual patient disease characteristics, promising a new era of precision medicine. But one of the hurdles doctors face is finding those patients quickly, accurately, and efficiently. »

She adds about Owkin Dx RlapsRiskBC and Owkin Dx MSIntuit CRC solutions:

“Our first approved diagnostic solutions could help millions of breast and colorectal cancer patients get the treatments they need sooner. This is a pivotal moment in Owkin’s mission to use AI to better understand diseases and develop more accurate diagnoses and treatments for patients. »

The RlapsRisk BC solution

RlapsRisk BC is an AI-based prognosis solution designed to predict the likelihood that a person with early breast cancer (ER+/HER2-) will relapse after treatment, allowing oncologists to determine which high-risk patients can benefit from targeted therapies and which low-risk patients can potentially avoid chemotherapy.

It was developed in collaboration with the Institut Gustave Roussy, the leading center for the fight against cancer in Europe, after Owkin won the 2019 “AI for Health” challenge from the Île de France Region.

Assessing the risk of relapse, thanks to AI, after treatment from digital images of tissue samples will really change the management of breast cancer care. Currently, patients with breast cancer at risk of relapse are identified by costly and time-consuming molecular or genetic tests. RlapsRisk BC offers performance comparable to standard molecular tests, while using data that is much more easily accessible, which reduces turnaround times (about fifteen minutes) and democratizes access to precision medicine.

Dr. Magali Lacroix-Triki, MD, PhD, pulmonology specialist in the Department of Medical Biology and Pathology at the Institut Gustave Roussy, says:

“AI-based digital pathology diagnostics could help us provide a comprehensive analysis of each tumor from a single representative tumor slide stained per calibrator, in a complementary process to the pathologist’s diagnosis. This would democratize access to precision medicine, opening a new era of treatment for patients around the world. »

MSIntuit CRC is an AI digital pathology diagnostic solution that preselects a biomarker in colorectal cancer tumors known as microsatellite instability (MSI), a defect in a cell’s ability to correct errors that occur when DNA is copied. This diagnosis excludes microsatellite stable (MSS) phenotypes, allowing pathologists to focus their resources on confirming patients with MSI.

Based on the deep learningshe was trained on hundreds of patient samples until she could accurately detect the presence of MSI in images of tumors. Its accuracy has been validated by a blind validation clinical study on hundreds of other patient samples.

It allows physicians to more effectively screen patients than with standard testing techniques, which include time-consuming polymerase chain reaction (PCR) or immunohistochemistry tests and patient tissue samples.

Additionally, patients with high MSI tumors are eligible for treatment with the new immunotherapy drug pembrolizumab, which a 2020 clinical trial found led to significantly longer progression-free survival compared to standard treatment. when received as first-line therapy for MSI-H-dMMR metastatic colorectal cancer.

Professor Magali Svrcek, MD, PhD, Sorbonne University, AP-HP, Saint-Antoine Hospital, Department of Pathology, Paris, said:

“As colorectal cancer is the third most common cancer in the world, it is crucial that we are able to screen patients for the biomarkers that make them eligible for potentially life-saving treatments. dMMR/MSI screening should be performed on all colorectal cancer patients, but pathologists’ time and resources are often overstretched. »

She concludes:

“Owkin’s new AI diagnostic solution, MSIntuit CRC, will account for approximately half of the number of cases requiring screening. It is designed to help more patients receive treatment sooner. AI-based digital pathology algorithms like these, developed in consultation with pathologists, will soon become an integral part of our daily practice. They will help patients get the best treatment for them sooner – a new era of personalized medicine. »

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