Automated, Reagent- and Scanner Independent CE-IVD Module for Her2-IHC Assessment in Breast Cancer- Validated on Data from More than 170 Pathology Labs

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Visiopharm A/S, a global leader in Quantitative Digital Pathology, announced today release of its novel CE-IVD module HER2-CONNECT for assessing Her2 status in breast cancer patients

Without any requirements for manual outlining of tumor cells, the level of automation is very high.

In summary, HER2-CONNECT™ showed 94% agreement with manual scoring and 95% diagnostic sensitivity and 99% diagnostic specificity.

As the first in a series of innovative CE-IVD diagnostic modules for cancer, Visiopharm is now releasing the HER2-CONNECT™ module in Europe for assessment of Her2 status in breast cancer patients.

In close collaboration with the NordiQC, the clinical performance of HER2-CONNECT has been determined by three studies comprising 796 tissue specimens prepared from breast carcinomas from 222 patients, using 6 expert reviewers/pathologists and representing 178 clinical pathology laboratories using DAKO, Roche-Ventana, Leica-Bond, and other HER2 IHC reagents. In summary, HER2-CONNECT™ showed 94% agreement with manual scoring and 95% diagnostic sensitivity and 99% diagnostic specificity.

Without any requirements for manual outlining of tumor cells, the level of automation is very high. Automation is achieved using a novel and patent pending principle of membrane connectivity for membranes detected in the tissue under examination [1,2 ].

Professor Mogens Vyberg, Director of the NordiQC, states: “Three requirements must be met in order for Digital Pathology to be useful in a routine diagnostic setting: It must be independent of reagent manufacturer and based on optimized and standardized staining procedures, exhibit high diagnostic performance in terms of sensitivity and specificity, and finally it must provide a high degree of automation. Our studies, of which some are still under preparation for publication, have demonstrated that the HER2-CONNECT™ module meet those requirements”.

"This is our first CE-IVD module in a series of modules coming out of our development pipeline. In our development, we are focusing on robustness, diagnostic quality, and last but not least automation. The critical step here is clinical validation and technical documentation. Visiopharm has invested significant resources in establishing the internal procedures and a quality system allowing us to develop, validate, and release CE-IVD modules for diagnostics in Europe", adds Johan Doré, CTO and co-founder of Visiopharm.

“We have now established the necessary platforms for rapid development of new image analysis algorithms and for providing comprehensive technical and clinical documentation. This will allow us to further accelerate an ambitious development program for new innovative techniques in diagnostics and companion diagnostics. We are doing that in collaboration with what we consider to be world-leaders in quality- and evidence based pathology”, says Michael Grunkin, CEO and co-founder of Visiopharm.

[1]: Brügmann, A., Eld, M., Lelkaitis, G., Nielsen, S., Grunkin, M., Hansen, J.D., Foged, N.T. & Vyberg, M., Digital image analysis of membrane connectivity is a robust measure of HER2 immunostains. Breast Cancer Res Treat. 2012; 132:41-9.
[2]: Laurinaviciene, A., Dasevicius, D., Ostapenko, V., Jarmalaite, S., Lazutka, J. & Laurinavicius, A. Membrane connectivity estimated by digital image analysis of HER2 immunohistochemistry is concordant with visual scoring and fluorescence in situ hybridization results: algorithm evaluation on breast cancer tissue microarrays. Diagn Pathol, 2011, Vol. 6, pp. 87

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Michael Grunkin
Visiopharm
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