Mindpeak has received CE-IVD mark for its artificial intelligence (AI)-based software, BreastIHC, which can identify and quantify breast cancer cells for primary diagnosis.
With this approval, the software will be made available to pathologists in Europe to help meet the rising need for cancer diagnostics.
The German company noted that this is the first approval for a deep learning solution that offers cellular level differentiation between tumorous and non-tumorous structures.
A plug-and-play software, BreastIHC will allow pathology labs to quickly identify, categorise and quantify breast cancer cells without complex system and calibration methods.
The AI software can categorise cells into positively stained tumour or unstained tumour cells.
As BreastIHC can distinguish between tumorous and non-tumorous structures, it enhances the scoring in the tumour microenvironment, the company noted
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Mindpeak CEO and founder Felix Faber said: “We are very excited about the CE mark as it allows us to empower pathologists to gain efficiency and increased accuracy in primary diagnosis.
“Our algorithm has proven in various tests that it works reliably under a wide range of laboratory conditions and can increase reporting speed and throughput enormously.”
For pathologists, identification and quantification of immunohistochemically stained breast tumour cells is considered an important task since the diagnosis will influence the therapy decision for cancer patients.
AI support could make this task less tedious and error-free and could cut down the mounting pressure on pathologists due to a surge in cancer cases.
The company said studies demonstrated that pathologists’ diagnoses differ in up to one-fifth of cancer cases.
Founded by Faber and Dr Tobias Lang, Mindpeak focuses on creating Al-based image recognition software for pathologists.
The company is collaborating with various international laboratories and pathology service providers to grow its product range and be part of the digitalised pathology workflow.