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Digital Cancer Diagnosis Platform

Periodic Reporting for period 1 - DCDP (Digital Cancer Diagnosis Platform)

Reporting period: 2018-12-01 to 2019-05-31

PROBLEM / ISSUE BEING ADDRESSED
Cancer diagnosis and prognosis is a global health priority. There are 3.7 million new cases of cancer and 1.9 million deaths from cancer each year in Europe. Recent advances in cancer treatment – precision medicine – show that personalised treatment programmes can significantly improve survival and improve treatment success. There is a recognised need for medical and technical developments which enable clinicians to rapidly and precisely diagnose cancers.

Over 100 million ImmunoHistoChemical (IHC) tissue sections are analysed by pathologists globally each year. Incumbent chromogenic IHC staining procedures are labour intensive, time consuming, expensive, waste valuable tissue and do not enable simultaneous analysis of multiple biomarkers in a single tissue section. Human subjectivity and the visual ability to identify spatial patterns limits the number of biomarkers that can be identified. Currently, there is no commercially available method for simultaneously and objectively analysing the spatial pattern of cells positive for multiple biomarkers.

The current process to identify four biomarkers in a tissue biopsy takes a day – this includes preparation of multiple tissue sections and assessment via microscope by an expert pathologist.

Chromition have developed an innovative and disruptive Digital Cancer Diagnostic Platform. The platform uses Chromition’s Luminspheres™ nanotechnology combined with novel spatial pattern image recognition software to diagnose cancer.

WHY IT IS IMPORTANT FOR SOCIETY
Cancer diagnosis is a key global healthcare priority and relies on timely, precise tissue diagnosis.

As pathologists are required to undertake more diverse tasks and required to examine more specimens, automated sophisticated image analysis will be required to maintain throughput in a timely manner.

The advent of personalised cancer treatment – precision medicine – has created an imminent need for rapid and precise prognosis and diagnosis of cancer. As therapeutic options increase there is a need to use multiple specific biomarkers to enable more precise diagnoses and therefore more tailored treatments.

The project will develop an innovative healthcare technology that will directly result in earlier, more efficient and effective detection and diagnosis of disease, which will enable proactive management of health conditions through the use of tailored treatments leading to better patient outcomes.

In November 2016, the International Consortium for Personalised Medicine was established with the aim to “establish Europe as a global leader in personalized medicine research.”

OBJECTIVES
The overarching objectives are to develop the Digital Cancer Diagnosis Platform into a fully tested and validated product for adoption by pathology and related services globally. The SME Instrument Phase 1 project specifically focussed on:

• Validating the technology in incumbent hardware
• Preparation of a robust business plan
VALIDATING THE TECHNOLOGY IN INCUMBENT HARDWARE
Chromition has developed and validated the technology in incumbent hardware during phase 1 of the SME-instrument. Multicoloured Luminspheres™ fluorescent biomarker labels have been prepared and coupled to an antibody-biomarker panel, which were used to selectively stain antigens in a single tissue section. An imaging platform was assembled comprising a microscope fitted with a UVA-light source and digital colour camera. The Luminspheres™ were shown to fluoresce simultaneously when irradiated with UVA-light and a digital-image captured by the colour-camera. The single multiplex image was evaluated using image analysis software that quantified the number of each colour Luminspheres™, position and spatial pattern. Currently, we are developing A.I. to stratify patients diagnosis and inform the optimal choice of personalised targeted treatment leading to better patient outcome.


BUSINESS PLAN STRUCTURE
A 77 page business plan has been prepared, the contents of which are outlined below.

Market structure
• Market segment definitions
• In vitro diagnostics
• Immunohistochemistry
• Fluorescent based imaging
• Nanoparticles
Market size
• In vitro tissue diagnostics market
• Immunohistochemistry market
• Biological imaging reagent market
o In vitro optical imaging market by application
o Nanoparticle market
• Microscopy imaging software market
• Main geographical markets snapshot
o North america
o Europe
o Asia-pacific
• Market channels and distribution
Market drivers
• Rising cancer incidences
• Growing geriatric population
• Growing healthcare spending
• Improvements in infrastructure for cancer diagnosis
• Growth in demand for personalised medicine
o Biomarkers in development for diagnostic and therapeutic applications
Regulations and standards
Patent landscape
Market challenges
• Regulatory restrictions
• Limited reimbursements
• Implementation of excise duty by u.s. government
• Increase in acquisitions
Market potentials and opportunities
Market trends
• Growing consolidation of the in vitro diagnostic market
• Incorporation of nanotechnology in immunohistochemistry
• Adoption of multiplex assays
• Automation in the immunohistochemistry market
• Increasing number of reagent rental agreements
Competitor analysis
• Porter’s five forces – industry competitiveness
• Competitor matrix
• Automated quantitative pathology imaging systems
Customer profiling
• Summary
• Current use of exiting solutions
• Current purchase behaviour
• Customer satisfaction and unmet needs
• Solution attractiveness
• Barriers to adoption
Business plan and commercialisation strategy
• Route to market
• Business model canvas for Chromition
• Commercialisation and exploitation plan
o Key partners
o Channels
o Key activities
o Value propositions
o Customer relationships
o Customer segments
o Cost structure
o Revenue streams
• Potential risks
BEYOND STATE OF THE ART
Large numbers of protein biomarkers are currently measured clinically in tissue sections by single-plex immunohistochemistry using multiple separate slides. Pathologists’ have to visually inspect the tissue sections to analyse the pattern of cells, which is time consuming and limited by the capabilities of the human eye to the use of 2 or perhaps 3 biomarkers.

There are currently two automated methods capable of measuring multiple biomarkers, but not the pattern, in a single section. These competing systems generate x,y coordinate data for cells positive for one or more biomarkers and have software for counting the number of cells positive for each biomarker. These systems stain the tissue sections with incumbent molecular fluorophore-biomarker conjugates that require sequential deposition, washing and separate visualisation using multiple light sources and are prone to photobleaching within a couple of minutes when irradiated. Neither system can analyse the pattern of cells and there is evidence that the order of staining the tissue sections influences the resulting images.

Chromition’s approach involves the use of exceptionally bright and stable Luminsphere™-antibody conjugates, that enables the single staining, single washing and simultaneous visualisation of multiple biomarkers and automated analysis. Significant commercial innovation emerges from combining Luminspheres™ technology with automated multispectral pattern analysis.

IMPACTS
The technology will transform the way clinical pathology is practised, by enabling high-throughput automated objective pattern analysis of the 100 million immunohistochemistry tissue sections globally each year. This in turn facilitates faster and more effective prognosis and diagnosis, better outcomes for patients, reduced treatment costs and improved treatment outcomes for patients. Being able to identify clinically useful patterns will improve the patient pathway by allowing patient selection for immunotherapy, avoiding unnecessary morbidity in likely non-responders. This will allow resources to be efficiently directed toward effective patient care.

The platform will be a key facilitator for the adoption of precision medicine within oncology. Also, it is less invasive to the patient requiring only a single tissue section; offers the patient earlier, more efficient and effective diagnosis of cancer; more detailed picture of disease status and progression; enables proactive management of health conditions through personalised treatment selection and improved treatment outcomes for patients.
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