Rare cell detection capability applied in various fields, from routine FISH testing to liquid biopsyIkonisys

A comprehensive range of Software Diagnostic ApplicationsIkonisys
OncoFish Applications

The Ikonisoft® suite presents a comprehensive range of applications meticulously designed to provide precise image analysis and intelligent classification of cellular nuclei, customized to suit the unique requirements of each assay. As we continuously strive to enhance our offerings, we regularly introduce new applications to our catalog.

Moreover, we actively seek collaborative opportunities with select partners for further development, ensuring that our solutions remain at the forefront of innovation and meet the evolving needs of our customers.


Any specimen, any diagnosis
The most versatile suite on the market

We develop both hardware and software to deliver the best product for FISH high productivity laboratories.
The integration of FISH within histology enables precise molecular analysis of tissue samples, facilitating enhanced characterization and understanding of cellular structures and genetic alterations within pathological specimens.
The incorporation of FISH in cytology enables detailed molecular analysis of cellular specimens, facilitating accurate identification of genetic abnormalities and providing valuable insights into cellular composition and function.
Liquid biopsy, incorporating FISH technology, revolutionizes cancer diagnostics by enabling non-invasive analysis of circulating tumor cells and cell-free DNA in bodily fluids such as blood or urine.
By detecting specific chromosomal aberrations, FISH allows for precise diagnosis, prognosis, and monitoring of hematological disorders, leading to improved patient management and treatment strategies.

oncoFISH her2

Amplification of the human epidermal growth factor receptor type 2 gene (HER2) is linked to negative outcomes in breast cancer patients. FDA-cleared HER2 amplification indicates better response to treatments like trastuzumab therapy and chemotherapy. oncoFISH HER2 is an automated microscopy application used to assess HER2 status in breast tissue biopsies. It analyzes tissue sections hybridized with HER2 and control probes.

The system scans marked areas of interest for HER2 status, providing accurate results and maintaining consistency. Automated imaging ensures a permanent record of cases without signal bleaching, aiding in case review and long-term documentation.

oncoFISH® bladder

Molecular biomarker techniques serve as valuable adjuncts to urine cytology and bladder cystoscopy in diagnosing urothelial carcinomas due to their limitations. The FDA-cleared oncoFISH bladder application offers a solution by scanning and analyzing cells from a voided urine sample fixed on a microscope slide.

Utilizing a panel of four FISH probes, it targets specific chromosomal regions associated with urothelial carcinomas. The Ikoniscope robotic microscope conducts three-dimensional imaging and analysis of cells and their FISH signals to detect aneuploidy or chromosomal deletions.

This automated process ensures quick scanning with high-quality images, reducing the limitations of manual analysis such as low throughput and fluorescence bleaching. Results, including cell images and tabulated data, are presented for review and reporting, streamlining the diagnostic process.


oncoFISH ALK is a fully automated microscopy application designed for the FISH-based detection of anaplastic lymphoma kinase (ALK) gene rearrangements, commonly associated with non-small cell lung carcinoma (NSCLC).

These rearrangements, particularly the EML4-ALK fusion, have been linked to abnormal cell proliferation in a subset of NSCLC patients. The identification of ALK rearrangements is crucial for selecting appropriate targeted therapies, such as the ALK kinase inhibitor crizotinib, which has shown promising results in clinical studies. FISH is well-suited for detecting the various ALK rearrangements, including the EML4-ALK fusion.

oncoFISH ALK utilizes break-apart probe-sets for sensitive and objective detection of ALK gene rearrangements, offering automated testing with reduced operator time and comprehensive, accurate results for efficient companion diagnostic use.


oncoFISH PTEN is an automated microscopy application designed for the FISH-based detection of PTEN gene deletions in prostate tissue biopsies. Prostate cancer, the most common cancer in men, poses significant health risks, with a notable association between PTEN gene deletions and more aggressive forms of the disease.

The integration of PTEN genetic information with routine histology offers valuable prognostic insights, aiding physicians in formulating tailored treatment plans for patients. The oncoFISH PTEN application allows precise scanning of tissue areas, referencing H&E or immunostained slides for analysis.

Utilizing high-resolution slide scanning, low magnification analysis identifies glandular tissue, followed by detailed analysis at higher magnification to determine PTEN deletion status in cells. This comprehensive approach enhances diagnostic accuracy and informs clinical decision-making in prostate cancer management.

Key features
World class built in software

we develop internally both the hardware controllers and the applications.
This approach allows the best synergy amongst hardware and software.
Seamlessly detect and classify signals within FISH images, ensuring consistent and reliable results through automated analysis.
Utilize a curated gallery of cells automatically selected by the software, enabling pathologists to swiftly validate outputs with confidence, without sacrificing precision.
Enjoy the flexibility of customizable parameters, empowering users to optimize analysis settings for higher throughput and adaptability to diverse assay requirements.
Immerse yourself in the world of FISH analysis with high-resolution, 3-D images that offer unparalleled clarity and depth, facilitating comprehensive examination of cellular structures.
Benefit from an open system that seamlessly integrates with various sample types, including cell suspensions and tissues, accommodating any probe for versatile analysis across a wide range of research and diagnostic applications.

Liquid biopsy / CTC
Circulating Tumor Cells

The Ikonisys platform, developed with a specific focus on rare cell detection and analysis, is exceptionally well-tailored for the identification and analysis of Circulating Tumor Cells (CTCs).

Its suitability for CTC detection and analysis was initially validated through collaboration with Sir Walter Bodmer's group at the University of Oxford, UK. Their work demonstrated that the Ikoniscope enables a straightforward and rapid procedure for the definitive identification of CTCs, marking a significant advancement in the field.


Circulating Tumor Cells (CTCs) offer insights into the individual characteristics of tumor cells, providing valuable information on their behavior and properties.

In contrast, circulating tumor DNA (ctDNA) offers a broader view of the tumor genotype, offering information on the overall genetic makeup of the tumor. Together, these biomarkers contribute to a comprehensive understanding of the tumor's biology and evolution, aiding in diagnosis, treatment selection, and monitoring of cancer patients.

Large number of cells examined

The Ikoniscope CTC application provides a flexible approach with no prerequisite sample preparation and no requirement for CTCs to express any particular biomarker. The ability to scan up to 2 million cells per slide allows samples to be analysed with no enrichment.

No enrichment needed

Detects all of the wide variety of CTC cell types, including epithelial and mesenchymal cells

Flexible approach

CTCs by FISH (for nucleic acids) as well as Antibodies (for proteins)

Discover the ikonisoft open platformIkonisoft®

Ikonisoft explorer tissue is an automated FISH scanning application for analysis of any tissue section hybridized with any desired combination of FISH probes.

No matter the tissue section, no matter the marker you are seeking—Ikonisoft explorer delivers results.

compatibile with any probe

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Ikonisoft Explorer Tissue is an automated FISH scanning application for analysis of any tissue section hybridized with any desired combination of FISH probes. This versatile application allows you to establish your own scanning and analytical parameters, simplifying complicated, labor-intensive assays of tissue sections.
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Ikonisoft Explorer CS is an automated FISH scanning application for analysis of any cell suspension deposited on a slide that has been hybridized with any desired combination of FISH probes. This versatile application makes cell suspension FISH assays faster and easier.

FDA & CE IVD cleared platform

FDA-cleared software designed to revolutionize medical imaging and analysis. This cutting-edge platform is meticulously developed to meet the rigorous standards set by the U.S. Food and Drug Administration, ensuring its safety,

Backed by extensive clinical validation and FDA clearance, our platform empowers healthcare providers with the tools they need to deliver optimal patient care and improve outcomes. Experience the future of medical imaging with our FDA-cleared platform today providing reliability, and effectiveness in clinical settings

Programming BIOS natively for hardware ensures optimal performance and stability by allowing direct control and fine-tuning of system components. This low-level programming approach provides the foundation for efficient hardware-software integration, crucial for maximizing the capabilities of the device.


Programming an operating system specifically for microscopes involves creating tailored software that efficiently manages hardware components, optimizes image processing, and supports advanced analytical functions. This specialized OS enhances the precision, usability, and functionality of microscopes, enabling researchers to conduct detailed and accurate scientific investigations.


Developing specific FISH (Fluorescence In Situ Hybridization) applications for microscopes involves creating software that automates the detection and analysis of fluorescent signals, improving accuracy and efficiency in identifying genetic anomalies. These specialized applications enhance the capabilities of microscopes in clinical diagnostics and research, providing vital insights into genetic disorders and cancer.



Creating an open configurator “explorer” for dealing with any kind of cell and probes would revolutionize cellular analysis, offering a versatile and user-friendly platform for customizing experimental setups. This tool would enable researchers to efficiently design, execute, and analyze a wide range of FISH and other cellular assays, fostering innovation and flexibility in scientific investigations.

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Unmatched Speed

Our FISH technology stands out for its unparalleled speed and precision. By employing advanced fluorescence probes, we enable the rapid identification of genetic abnormalities and chromosomal changes associated with various types of cancer.

This allows for quicker diagnosis and timely intervention, significantly improving patient outcomes.

FISH means
Early Cancer Diagnostics

Early cancer diagnosis is crucial for several reasons.
First and foremost, it significantly increases the chances of successful treatment and improves patient outcomes. Detecting cancer at an early stage allows for timely intervention, which can often result in less aggressive treatments and better prognosis.

Additionally, early diagnosis can help prevent cancer from spreading to other parts of the body, potentially reducing the need for extensive and invasive procedures. Moreover, it can lead to a better quality of life for patients and their families by minimizing the physical, emotional, and financial burden associated with advanced-stage cancer.

Overall, early cancer diagnosis plays a pivotal role in saving lives and enhancing the overall effectiveness of cancer care.
FISH technology in mass screening application has a potential to save millions of human lives.

Coming SoonDays left to the next generation Ikoniscope release

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Prices & packages

Ikoniscope 20
List Price, single Unit
  • Medium productivity
Ikoniscole 160 Max
List Price, single Unit
  • THe world's highest productivity
Pay per Test
Starting from
  • Device, Probes, software, setup, mantainance, all in one

Dark Room Real Pictures
of our FISH scans

High quality image for better diagnostics

Get in touch

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5 Science Park, New Haven, Connecticut
06511 - USA
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Ikonisys Inc.


Ikonisys, Inc.
5 Science Park, New Haven, Connecticut 06511, USA
Phone: +1.203.776.0791
Email: corporate@ikonisys.com


Ikonisys, SA
62, rue de Caumartin
75009 Paris
Email: investors@ikonisys.com


Ikonisys S.r.l.
Via dell’Ambrosiana,22
20123 Milano
Email: corporate@ikonisys.com

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