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Ikonisys Launches Next Generation of CTC Detection, Analysis Platform; Expands US Presence

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NEW YORK – Newly public cancer diagnostics company Ikonisys plans to expand the commercialization of its Ikoniscope20 rare cell capture and analysis platform in the US and Europe.

Ikonisys, which has offices in Paris and New Haven, Connecticut, completed its IPO in July, raising €4 million (about $4.5 million) through an offering of 700,000 new ordinary shares and listing on the Euronext Growth Paris exchange. The company plans to use the funds to accelerate its commercial development in both the US and Europe and for working capital, with approximately 20 percent of the financing going toward further research and development.

Ikoniscope20 is the newest version of the company's Ikoniscope platform, a fully automated workflow for the automation of fluorescent in situ hybridization assays, and the detection, isolation, and analysis of rare cells, with applications in circulating tumor cell (CTC)-based testing and personalized medicine.

The platform is designed to scan, analyze, and digitally image up to 2 million cells per slide, based on multiple biomarker combinations. This avoids limitations related to marker and size-specific enrichment approaches and makes it possible to develop a variety of specific CTC-based tests. High-quality imaging further enables detailed morphological cell analyses.

It consists of both hardware and software components, the latter of which can be optimized to perform different analyses as needed.

Potential tests range from detecting particular cancers to companion diagnostics meant to indicate the appropriateness of a particular therapy. Ikoniscope users can add other Ikonisys analysis products, such as the oncoFISH software application, to the Ikoniscope platform to customize assays as needed. While slides must still be prepared manually, the platform automates all scanning and imaging, as well as tabulating the classes of cells detected.

Ikonisys entered into a collaboration with Sheba Medical Center to develop some of these tests in 2019.

"Essentially, we have a single instrument capable of undertaking a wide range of tests," Michael Kilpatrick, CSO of Ikonisys, said via email. "In this way the platform can be customized with the desired number of software applications for a particular lab. Alternatively, the instrument can be purchased with software applications for an initial number of tests and additional tests added as desired."

The Ikoniscope20 became commercially available at the start of the third quarter of this year and the first installation is planned to occur in December at Tomalab, a molecular diagnostics lab in Busto Arsizio, Italy, outside Milan, where Ikonisys also has another office. Tomalab will perform several FISH tests and one CTC test on the new device.

"Compared to the [first-generation] instrument," said Kilpatrick, "the Ikoniscope20 is designed to be smaller, faster, and more flexible, meeting customers' requests and needs, while maintaining its core ability of detecting and quantifying rare cells in tissues and in biological fluids in a completely automated way."

Approximately 41 first-generation Ikoniscopes have been installed in the US and five have been installed in Europe, largely in diagnostic labs, several of which specialize in urology.

Acupath Laboratories, based in Plainview, New York, performs clinical diagnostics and has been a customer of Ikonisys since 2007.

"Incorporating the Ikoniscope into the workflow allowed for Acupath to take on additional volume of cases" using FISH assays, Michael Matthews, director of molecular diagnostics at Acupath, wrote in an email.

The platform's full automation and analysis capabilities, he continued, have provided the company with 24-hour analytical capabilities and associated cost savings. Use of the platform has roughly doubled the lab's slide analysis capacity, from a max of approximately 24 cases per day per technologist, to over 40.

"The cost savings are real and noticeable," Matthews said. "Acupath Laboratories is able to do over 400 cases a month with a limited staff due to the inclusion of the Ikoniscope into the workflow."

Other commercial automated platforms for FISH assays and rare cell detection exist. Matthews mentioned that while other platforms have their strengths, Acupath has found the Ikoniscope platform to have the best continuous slide feed operation, contributing to its ability to turn around a higher case load.

Acupath is currently evaluating the Ikoniscope20 as it considers installing the new platform.

The Ikoniscope20's utility in the immunology and immune-oncology fields is also being validated in an ongoing study in collaboration with the University of Connecticut School of Medicine.

The study aims to demonstrate the platform's sensitivity in isolating and identifying specific CD8 T-cell populations, as these rare cells play central roles in the immunity to cancers and infectious agents such as viruses.

"The plan is to have the necessary data to produce a manuscript for publication by the end of the year," Kilpatrick stated.

Ikonisys plans to expand its US operations by building a sales force and "field presence" there.

As a first step in this effort, the company hired Manny Iglesias as sales director for the US market in September. Ikonisys currently has eight US-based employees — out of 12 in total — and plans to add hires as Ikoniscope20 sales ramp up.

At the moment, the company is particularly looking for a service engineer and a specialized software developer.

Existing clients willing to replace their older Ikoniscope platform with the Ikoniscope20 will comprise the company's initial commercial targets.

In parallel, Ikonisys intends to expand its portfolio of Ikoniscope20 software applications, while broadening its commercial portfolio through reagent kits for customers using the Ikoniscope platform.

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