DiaDeep, a Lyon-based company specialized in medical AI for oncology pathology, achieves CE-IVDR Class C marking for DiaKwant™, a device that automatically analyzes cancerous tissue and supports doctors in therapeutic decisions.

We are excited and proud to receive this certification. It is a major milestone for DiaDeep, and it enables us to provide our pathologist partners with tools they can rely on when making therapeutic decisions. Class C is the most stringent level under the IVDR regulation: it confirms that DiaKwant™ meets the highest requirements for safety, performance and risk management. To our knowledge, DiaKwant™ is the first CE-IVDR marked medical device to simultaneously cover the biomarkers for hormonal therapy, chemotherapy and immunotherapy. This is the result of three years of work with clinicians, for clinicians.
Sanae Salhi, CEO and co-founder, DiaDeep

When tumor analysis determines treatment

When cancer is diagnosed, doctors must determine which treatment will be most appropriate for the patient. This decision relies heavily on microscopic analysis of tumor tissue, carried out by specialist physicians called pathologists. They identify the biological characteristics of the tumor that indicate whether a patient can benefit from immunotherapy, targeted therapy, or hormonal therapy.

This analytical work is meticulous, time-consuming, and under increasing pressure: cases are growing in number and complexity, while the number of available pathologists in Europe is declining. In this context, artificial intelligence can provide meaningful support.

What DiaKwant™ does

DiaKwant™ is a CE-IVDR Class C marked in vitro diagnostic medical device that automatically analyzes digitized cancer tissue slides. The software examines an entire slide and produces a quantified result on seven key biological markers, directly usable by the medical team.

The DiaKwant™ PD-L1 algorithm assists pathologists in the automated quantification of TPS and CPS scores on whole slide images, in breast, lung and digestive cancers, to guide immunotherapy decisions. Validated across six tumor types, this algorithm is part of DiaKwant™, which integrates all immunotherapy biomarkers in a single CE-IVDR marked device.

The DiaKwant™ HER2 algorithm assists pathologists in assessing HER2 status in breast and gastric cancers, to guide targeted therapy decisions. This algorithm is part of DiaKwant™, which covers all chemotherapy biomarkers used in routine clinical practice.

The DiaKwant™ Ki-67, ER and PR algorithms assist pathologists in evaluating hormonal and proliferative biomarkers in breast cancer, to guide hormonal therapy decisions. These algorithms are part of DiaKwant™, which is to our knowledge the only CE-IVDR marked device to simultaneously cover the biomarkers for hormonal therapy, chemotherapy and immunotherapy.

DiaKwant™ is distributed by Roche Diagnostics and integrated into the Sectra environment, enabling pathologists to access the device directly from their daily tools. The device is deployed in six pathology laboratories in France.

The European In Vitro Diagnostic Regulation (IVDR, EU 2017/746) establishes a rigorous regulatory framework for diagnostic devices within the European Union. Class C applies to devices whose results directly contribute to therapeutic decisions. The DiaKwant™ certification, issued by TÜV SÜD, confirms that DiaDeep complies with the requirements of the IVD Regulation (EU 2017/746).