KUALA LUMPUR, June 1 (Bernama) -- Stratipath, a global leader in AI-based precision diagnostic solutions, has announced its AI software for prognostic risk stratification of breast cancers, Stratipath Breast, is now CE-IVD marked.
According to a statement, this paves the way for clinical implementation in the European Union.
“Stratipath Breast offers a faster and cheaper alternative to molecular assays, allowing more patients to have access to precision diagnostics. By using Stratipath Breast, clinicians can diagnose with support from prognostic information, while reducing laboratory time and costs,” said professor in pathology at Karolinska Institutet, Stockholm, and co-founder of Stratipath, Johan Hartman.
Based on the analysis of digital histopathology whole slide images, stained with haematoxylin and eosin (H&E) the software provides novel decision support toclinicians and enables precision medicine for more patients.
Stratipath Breast is the first EU regulatory compliant solution for risk stratification of breast cancer using AI-based precision diagnostics to analyse cancer tissue, and enabling identification of patients with increased risk of disease progression.
In contrast to traditional molecular tests, AI-based risk stratification enables faster turnaround times for results, provides new information at the point of diagnosis and reduces the need for expensive molecular testing, allowing for wider use and benefit to more patients.
Using deep learning, Stratipath Breast enables cancer detection and classification of intermediate risk tumours into low and high-risk groups, based on grade-related tumour morphology.
The stratification comes from a rigorous scientific development process and validation using multi-source real-world datasets, comprising histopathology images and associated clinical outcome data.
The system measures risk-associated morphological patterns locally in the image and aggregates this information across the analysed tissue area to establish whether the tumour belongs to the high or low-risk group.
Results from Stratipath Breast provide prognostic information and are intended to be used as a decision support tool, together with other clinical and pathological information.
Stratipath Breast provides an optimal workflow through integration with leading digital pathology solutions. It can also be used on its own, via the Stratipath customer web portal.
-- BERNAMA
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