A rapid, low-cost, cervical cancer screening platform

Project Information

HoloCyt

Grant agreement ID: 744918

DOI

10.3030/744918

Project closed

EC signature date 9 December 2016

Start date 1 January 2017

End date 30 June 2017

Funded under

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

OVIZIO IMAGING SYSTEMS
Belgium

Periodic Reporting for period 1 - HoloCyt (A rapid, low-cost, cervical cancer screening platform)

Reporting period: 2017-01-01 to 2017-06-30

Summary of the context and overall objectives of the project

Ovizio is a Belgian company that develops and commercializes quantitative microscopic imaging devices based on patented Digital Holographic Microscopy. The technology provides real-time imaging data that identifies cells based on a unique label-free “holographic” fingerprint. The company has focused its initial efforts on the Bioprocess industry serving large pharmaceutical customers and is now looking to expand to the diagnostics industry, where the company’s core technology has the potential to yield significant value given its ability to discriminate healthy cells from cancer cells. The company will initially focus on cervical cancer diagnostics.
Cervical cancer causes 250.000 deaths and 500.000 new cases every year globally. It has been demonstrated that early detection and regular government organized screening programs drastically reduce the effects and impact.
Today two tests are performed to diagnose cervical cancer:
1. a cytology based Pap smear test where a cervical sample is analyzed by a pathologist via visual inspection using traditional or automated microscopy.
2. a molecular test detecting the presence of HPV infections generally performed on highly automated instruments, located in centralized labs.
Results are typically available after 2 to 3 weeks causing anxiety and frustration for the patient. Typical instruments are expensive and have high related operational costs requiring many process steps. Moreover, PAP testing is associated with a high rate of false negatives and hence a significant chance of missing cases, where as HPV testing is associated with a significant rate of false positives resulting in too many colposcopies, unnecessary anxiety and expensive treatment procedures.
Ovizio has designed a direct read vial allowing for a cervical sample to be directly analyzed without manipulation at the point of care or in a central lab. The technology automatically generates objective data, identifying cells, detecting the HPV infections and detecting malicious cells providing the combination of cytology, HPV detection and identification of precancerous cells in a single low-cost test, performed on a device giving results in minutes rather than days allowing for near patient testing.
A proof of concept and alpha prototypes have been built with basic software algorithms. Several hundreds of tests have been performed at 2 hospital sites in Belgium and 3 in France resulting in two scientific publications and enthusiasm from key opinion leaders.
The breakthrough technology provides an answer to the emerging need of co-testing that has already shown improved sensitivity and specificity when compared to either a cytology or HPV test separately. And therefore has the capacity to reduce the burden of cervical cancer on our society by early and improved detection.
The overall objective of the SME phase I project was to perform an economic, social and technical feasibility study to identify the next steps preparing for EU-wide market launch. The following steps will focus on developing and clinically validate instruments for cervical cancer screening ready for commercialization in Europe and in the United States.
The company has an experienced team with skilled technical and commercial experts that has launched innovative products in the past, laying the foundations for this project.
Based on the results of the SME phase I project, Ovizio enforced its plans to apply for an SME phase 2 project providing the financial needs to prepare for market launch. This will allow the company to deploy its technology to Key Opinion Leaders faster and to onboard dealers efficiently.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The specific objectives of the feasibility study and results achieved are summarised in the table below:
Objectives:
- Performing a voice of customer survey to validate commercialisation and go-to-market strategy;
- Securing additional patent applications to cover and protect the specific detection methodology;
- Validating regulatory pathways (Belgium, Luxembourg, France, Germany and Italy);
- Developing a clinical support validation plan in concertation with consultants and regulators;
- Evaluating impact of new regulations (ISO 13485:2016 and CE-IVD);
- Updating and finalising business plan
Results:
- 10 interviews were conducted with experts in France, Belgium, the UK and the United States
- Our patent portfolio was analysed by a new patent lawyer and we filed a continuation of our awarded (USA) base diagnostic patent, protecting the HoloCyt application we also expanded the claims of the European patent application
- We held regulatory sessions with experienced consultants in Europe with Gert Bos (Partner at QServe) and in the US with Mark J Sarno (Vison Clinical research LLC) and defined the regulatory pathway for these regions
- We made a draft clinical validation plan and defined the number of clinical tests to be performed based on discussions and research
- We evaluated the new European regulations and their impact and decided to prepare for filing in compliance with these new regulations
- We finalized and updated our business plan
The SME phase 1 grant has enabled the company to identify a methodology to overcome market barriers and to solidify the business plan and financial needs in anticipation of a funding round.
Ovizio’s management has decided to spin-out the diagnostics unit in 2018. The new company will take over all active diagnostics projects within Ovizio and recruit additional staff. The main decision criteria for spinning of this entity are the different natures of business when compared to Ovizio’s already operational business within the bioprocess industry, the different profile of potential investors in the diagnostics field and the experience and skill set of staff members required to bring the products to the market. The spin-off will recruit additional scientific and managerial staff with experience in a similar environment.
Ovizio’s spin-out will sell a solution that comprises a device (holographic microscope) and related software, a consumable prefilled with a fixation and preservation liquid and a range of extended warranty services on a pay per test basis.
The device will be positioned as a better alternative to existing solutions as it performs a cytological test, an HPV test and a pre-cancerous cell detection test in a single device in minutes rather than hours and with better specificity and sensitivity.
The company will reach end users comprising
- in the first phase of commercialization:
- Clinical diagnostic laboratories
- Physicians' office laboratories
- Hospital laboratories
- In the second phase: gynecologists and practitioners directly for point of care testing.
Ovizio’s spin-out will rely on a carefully selected network of dealers throughout the world to support it’s commercialization process.
The initial focus of the company will be a roll out in Europe, more specifically in Belgium and France (2019), followed by the other main European countries in 2020 (Germany, United Kingdom, Italy and Spain), the rest of Europe in 2021 and a full roll out in the US as from 2022. In the first year of commercialization Belgium and France have been selected because of the already existing relations with labs and key opinion leaders (KOLs), relations with authorities and a favorable climate for co-testing.
The main goal- of Ovizio is to promote its technology through government sponsored screenings programs. The company will therefore participate in exhibitions and trade shows such as Eurogen in France. Publications by Key Opinion Leaders in the field are essential for the promotion of the technology and the adoption by scientific organizations. The main focus will be to created interest from key end-users.
Ovizio estimates that product development and clinical validations will cost about 30 M€ over the initial 3 years.
Prior to the submission of an SME phase II proposal, Ovizio will first further perform preliminary clinical test. Ovizio plans to roll out its full validation and comercialisation programme as of mid 2017, submitting it’s SME phase II proposal in early 2018.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Preliminary pre-clinical results indicate an improved sensitivity and specificity when compared to current gold standard tests. This would result in an improved detection of positive cases and reduced false positives giving more cancers detected in an early stage and less unnecessary treatments for falsely diagnosed samples reducing the overall burden on the social security systems of the member states.
As the HoloCyt technology will be available at a lower cost compared to current technologies the solution will allow to improve the financial performance of the labs purchasing the instrument and a reduction in total cost of the government organized screening programs.

Automated alpha prototype device

Alpha prototype device

The C-Box direct read vial

Segmented cells and detected nucleoli

Ovizio Company Infographic