Regulatory News:

Ikonisys SA (ISIN Code: FR00140048X2 / Ticker: ALIKO), a company specializing in the early and accurate detection of cancer with a unique fully-automated solution for medical diagnostic labs, today announces the successful completion of a study, undertaken in collaboration with the Carole and Ray Neag Comprehensive Cancer Center of the University of Connecticut (UConn) School of Medicine, for the detection of extremely rare cells in the field of immune-oncology with the Ikoniscope 20.

The study thus demonstrates the ability of the Ikoniscope20 platform to detect rare, clinically significant, specific populations of CD8 T cells, at a sensitivity and frequency higher than that obtained by flow cytometry, the standard tool used for such detection, and via other rare cell detection methodologies. In addition, such a microscopy-based approach provides the ability for detailed morphological analysis of detected cells of interest.

The project demonstrates the potential superiority of the Ikoniscope20 automated fluorescence microscopy platform for accurate enumeration of a cell sub-population of clinical interest over a more traditional approach such as flow cytometry.

Moving forward, this approach could be applied to the enumeration of the CD8 cells of interest within the tumor infiltrating lymphocytes obtained from specific tumor types. More broadly, this provides a proof of principle that the Ikonisys platform is fully suited for detection of rare cancer cells in blood or other body fluids without a need for prior enrichment. It also demonstrates the ability of the Ikoniscope20 platform to compete with more costly flow cytometry instruments, and perform immune monitoring functions more effectively, inexpensively, and easily, and opens other commercialization opportunities of the Ikoniscope20, as a tool used by research laboratories for immune response monitoring.

A manuscript, for publication in a peer-reviewed journal, reporting the results of the study, is currently in preparation.

Pramod Srivastava PhD MD, Director of the Neag Cancer Center, says: “There is a fast-growing need for monitoring the many experimental and newly approved immunotherapy treatments for cancer patients, as well as for research studies in animal models. These results show a new path towards fulfilling that unmet need.”

Dr. Michael Kilpatrick PhD, Chief Scientific Officer of Ikonisys, added: “We are very pleased to have been able to bring to success this project, that provides proof of principle for the use of our technology also in immuno-oncology. Working with a leading medical center to further demonstrate the potential of the Ikoniscope20 platform in the detection and quantification of clinically relevant immune cells has been an honor and continues to demonstrate the growing potential of our automated fluorescence microscopy platform to penetrate new markets.”

About Ikonisys Ikonisys SA is a cell-based diagnostics company based in Paris (France), New Haven (Connecticut, USA) and Milan (Italy) specialized in the early and accurate detection of cancer. The company develops, produces and markets the proprietary Ikoniscope20® platform, a fully-automated solution designed to deliver accurate and reliable detection and analysis of rare and very rare cells. Ikonisys has received FDA clearance for several automated diagnostic applications, which are also marketed in Europe under CE certification. Through its breakthrough fluorescence microscopy platform, the company continues to develop a stream of new tests, including liquid biopsy tests based on Circulating Tumor Cells (CTC).

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