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FP7

SelfPOCNAD Sintesi della relazione

Project ID: 605889
Finanziato nell'ambito di: FP7-SME
Paese: Norway

Final Report Summary - SELFPOCNAD (SelfPOCNAD - Development of a Point of Care Detection Device and Self Sampling Device for Cervical Cancer Screening –)

Executive Summary:
We have successfully concluded a Research for SMEs project and shown that rapid (“same day”) Invasive Cervical Cancer (ICC) screening of self-taken patient samples is possible. The follow on selfPOCNAD project is to develop a commercial pre-production prototype point of care test for invasive cervical cancer (ICC). This easy-to-use lab-on-a-chip system (selfPOCNAD) will enable women to collect samples in the comfort of their own homes and take them into a GP surgery for testing and provision of immediate results. This will dramatically increase compliance of women with the ICC screening programs will and drastically decrease the ICC incidence and save lives

ICC is the second most common cancer in women. Each year, there are over 470,000 new cases globally. Of these, 33,000 are in the EU. Once the disease is established, it is hard to cure, so each year 233,000 women die - 15,000 in the EU[1]. After breast cancer, it is the second-most-common cancer amongst women. However, this is a preventable and treatable disease, if detected in the early stages. Some EU member states have well-organised screening and effective prevention programmes. But better compliance with screening using this inexpensive lab-on-a-chip system, especially in New Member States, could save the lives of 3-5,000 European women p.a.

This current demonstration project is to develop a commercial pre-production prototype point of care test for invasive cervical cancer (ICC). This easy-to-use lab-on-a-chip system (selfPOCNAD) will enable women to collect samples in the comfort of their own homes and take them into a GP surgery for testing and provision of immediate results. This will dramatically increase compliance of women with the ICC screening programs will and drastically decrease the ICC incidence and save lives. It will enable the SelfPOCNAD consortium to prove that they have a technological and commercially sound proposition. It will also allow them to secure investment by either a major blue chip company or an investment house to fund the scale up to production of this life saving and commercially attractive Point of Care (POC) test

Project Context and Objectives:
We have successfully concluded a Research for SMEs project and shown that rapid (“same day”) Invasive Cervical Cancer (ICC) screening of self-taken patient samples is possible. Our novel solution consists of two parts;
(i) a self -sampling device used by patients in the privacy of their own home, and
(ii) a detection unit with disposable sample container and micro fluidics chip situated at POC to where the patients will deliver their samples.

The detector system prepares the sample, and then performs the test to produce robust ICC screening results in less than 3 hours. These are communicated to the patients the same day, relieving the unnecessary anxiety that exists today when patients have to wait up to a week for their results and allowing any necessary treatment to start. This is far quicker than alternative testing regimen, where results are rarely communicated to the patient within a week.

This current demonstration project is to develop a commercial pre-production prototype point of care test for invasive cervical cancer (ICC). This easy-to-use lab-on-a-chip system (selfPOCNAD) will enable women to collect samples in the comfort of their own homes and take them into a GP surgery for testing and provision of immediate results. This will dramatically increase compliance of women with the ICC screening programs will and drastically decrease the ICC incidence and save lives. It will enable the SelfPOCNAD consortium to prove that they have a technological and commercially sound proposition. It will also allow them to secure investment by either a major blue chip company or an investment house to fund the scale up to production of this life saving and commercially attractive Point of Care (POC) test.

Our concept is the introduction of a self-sampling mRNA based ICC screening at POC that will make it possible to identify cervical pre-cancer earlier and hence, reduce the national incidence of ICC1. A simple lab-on-a-chip system and self-sampler will reduce the need for women to have vaginal or cervical samples taken at clinics and gynaecological offices and improving the coverage rate for ICC screening. Our self-sampling, point-of-care (POC) system uses nucleic acid detection (NAD) – hence the name SelfPOCNAD.

The project goals are to;
• Develop a detailed market exploitation strategy, containing manufacturing details and a complete business plan to reach the global market and development supply chains with distributors in Asia, Africa and the USA.
• Develop tools and techniques to produce and assemble consumables (microchips, cassette, and sample container)
• Produce a prototype detection unit that complies with all medical device and industrial requirements
• Validate the system in a clinical setting, against standard benchmark tests
• Demonstrate the total SelfPOCNAD solution to potential partners or investors, backed up by a compelling business case and convincing market entry plan and global production strategy.

Project Results:
The novel solution consists of two parts;
(i) a self -sampling device used by patients in the privacy of their own home, and
(ii) a detection unit with disposable sample container and micro fluidics chip situated at POC to where the patients will deliver their samples.
The detector system prepares the sample, and then performs the test to produce robust ICC screening results in less than 3 hours. These are communicated to the patients the same day, relieving the unnecessary anxiety that exists today when patients have to wait up to a week for their results and allowing any necessary treatment to start. This is far quicker than alternative testing regimen, where results are rarely communicated to the patient within a week.
Overall, the project is expected to greatly the increase competitiveness of European SMEs in the medical device sector in POC and in vitro diagnostics (IVD) market segments that are currently dominated by the large international players and SMEs from the USA.
To achieve this growth, we need to capitalise on the results of our successful R4S project SelfPOCNAD where we have achieved proof of concept and secured a working per-production prototype. To demonstrate that we have a solution worthy of substantial further investment from a global player, we have validated the following
• Developed the basic laboratory prototype of the detection unit further so that it meets the necessary medical device standards and industrial requirements
• Developed the tools and techniques to produce and assemble consumables i.e. cartridge and sample container which meet target prices
• Performed tests with clinical samples to demonstrate that SelfPOCNAD works in a ‘real world’ setting and verified these test results against standard clinical bench marks
• Developed a detailed market strategy, manufacturing dossier and business plan to reach the global market and develop supply chains with distributors in Asia, Africa and USA.
The overall objectives of the WP1 were:
• To carry out technical due diligence from the previous project and collate all the results including the deliverable reports and a technical presentation from the RTD performers at the kick-off meeting.
• To agree technical and business development factors for successful demonstration
• To determine the precise nature of the testing with clinical samples and decide on materials/consumables requirements. Agree with the partners related to the protocol of the clinical validation.
• Recruit the Advisory Board and agree on a unified objectives for the project

The purpose of work package 1 was to carry out technical due diligence from the previous project and collate all the results including the deliverable reports and a technical presentation from the RTD performers at the kick-off meeting. In order to demonstrate and test the SelfPOCNAD system prior to starting the demonstration project a variety of tests were performed of both the system and the technique.
Significant Achievements in Work Package 1 included
• Non-stop run of the system for more than 48 hours
• Positive NASBA signals in some cassettes
• Development of a business plan
• Development of a financial template to assess the cost to launch of the product
• Development of a technical plan for the Demo project
• Development of a technical plan through to launch
• Technical and business development plan agreed with the partners
• A business roadmap presented in the business plan
• Two potential sites have been identified as ideal for the point of care testing
• An ethical approval application has been sent and the plan for further trials in clinical settings have been approved
The overall objectives of the WP2 were:
• A Design for Manufacture exercise to modify the basic laboratory prototype of the instrument so that demonstration versions can be produced.
• A Design for Manufacture exercise to modify the basic laboratory prototype of the sample tube and cartridge so that the components (tube, microchip, cassette) can be assembled into sufficient quantities of packaged consumables for demonstration trials.
• A proposal for a future high-volume production line will be suggested and described in detail.
Work in WP2 allowed completion of the design for manufacture exercise to modify the basic laboratory prototype of the instrument so that demonstration versions can be produced. A concept for a low volume production line was generated to enable initial production. The METIS 4.0 production platform standard has been developed to be able to accommodate SelfPOCNAD cassettes in medium/high volume and to fit the type of Lab-on-a-chip product.
Significant Achievements in Work Package 2 included:
• Low-volume production concept demonstrated.
• High volume production concept demonstrated
• METIS 4.0 prototype developed and displayed at Motek trade fair.
• Updated cartridge design solving earlier design flaw and increased reliability of cartridge design.
• Validated handling methods for various components in the cartridge.
• Bead production process flow and production concepts developed
• List of standards and quality procedures prepared
• Methods to work RNase free in a production environment to ensure high quality production of the SelfPOCNAD products
The overall objectives of the WP3 were:
• To manufacturing pre-production prototypes of the instrument.
• To manufacturing pre-production prototypes of the sample tube and cartridge, suitably packed for and demonstration activities
Work in WP3 carried included upgrading of the POCNAD instrument from the research project to a suitcase instrument that was able to be transported and demonstrated and two further instruments were prepared incorporating improved optics, heating device and the magnetic concentration. Around 250 cassettes, 800 chips, 500 nanoliter of freeze dried reagents were also produced and integration of neural network based vision to IMS portfolio and use in production of SelfPOCNAD quality control.
Significant Achievements in Work Package 3 included:
• Developed a stable prototype POCNAD
• Developed a prototype suitcase instrument functional robust and possible to transport
• Developed further two prototype simple instruments for testing optics, heating device and the magnetic concentration
• 250 cassettes, 800 chips, 500 nanoliter of freeze dried reagents produced and 50 cassettes assembled including chips.
• Gained knowledge on novel vision inspection method using neural networks as a programming method.
• Vision method usable in POCNAD device quality inspection.
• Overview of required and feasible dispensing solutions as applicable in the SelfPOCNAD product assembly
The overall objective of WP4 was:
• To demonstrate that the SelfPOCNAD solution works with clinical samples in a POC setting
Work in WP4 entailed a continuous evaluation of the hospitals and national screening programmes and accordingly planning for validation of the SelPOCNAD solution. Leading to testing of the clinical samples as well as benchmarked against existing screening techniques ensuring in both cases that that the biological samples from humans are treated in accordance with the regulations and the Ethical Approval steps have been completed and documented properly.
Significant Achievements in Work Package 4 included:
• Ethical approval for collecting samples for trials in clinical settings filed
• A complete evaluation of hospital and national screening programmes and clinical data world-wide was undertaken including review of the evaluation.
• Two recent very large studies in USA and Norway concluded that the PreTect technology used in the POCNAD cartridge may represent the only true medical gold standard technology
• The process of RNA/DNA extraction inside the POCNAD cassette accomplished
• Enough high quality RNA/DNA extracted from clinical samples within the POCNAD cassette
• The RNA/DNA extracted from the POCNAD cassette gave strong NASBA signals
• 60% of the 51 clinical samples gave high quality RNA/DNA within the POCNAD cassette extraction system
• The artificial human mRNA and E6/E7 mRNA i.e. same sequence DNA oligo successfully used in the validation of the POCNAD cartridge
The overall objective of WP5 was:
• Preparation of a Business case to secure investment and IP protection.
Work in WP5 related to a patent search and analysis undertaken on the IPR for the SelfPOCNAD project. This has confirmed that there is novelty in the project and that the IPR is protectable. The demonstration of the POCNAD instrument and cartridge, the validation process and the production procedure and practical steps were done in front of the primary health expert, the demonstration was approved to be according to what were claimed within the whole process of demonstration. A number of proposals have been made for technology transfer to other diseases,
Significant Achievements in Work Package 5 included:
• Patent search and freedom to operate established
• Identification of potential new IPR in demo phase of project
The overall objective of Work Package 6 was:
• Stakeholder Presentations.
Work in WP6 related to the demonstration of the POCNAD instrument and cartridge, the validation process and the production procedure and practical steps were done in front of the primary health expert. Widespread dissemination activities have been undertaken including the POCNAD technology presented at the main exhibition at the MicroTAS organised under the Norwegian Center of Expertise, Micro and Nanotehnology.
Significant Achievements in Work Package 6 included:
• Agreement on IPR holding model
• A further patent application has been made on Device and Method for Refining Particles that is directly relevant to Self POCNAD DEMO project
• The POCNAD instruments and cartridge demonstrated in front of the primary health expert and he reported satisfactory results following the given claims

Potential Impact:
The easy-to-use lab-on-a-chip system (selfPOCNAD) will provide a point of care test for invasive cervical cancer (ICC) that will enable women to collect samples in the comfort of their own homes and take them into a GP surgery for testing and provision of immediate results. This will dramatically increase compliance of women with the ICC screening programs will and drastically decrease the ICC incidence and save lives.

It is estimated that the application will take the market of primary screening increasing the sales of Self POCNAD to 10 million in 2020, 50 million by 2025 and 200 million in 2030.
The production cost of each instrument will be between €400 - €640 depending on volume and we expect each GP surgery will have 1 – 3 of these instruments. We plan to produce the SelfPOCNAD cartridge for less than €4 with a production volume of 100,000 per year. With a volume of more than 1 million per year we hope that the production cost will be less than €1.
Self POCNAD and the combination of POCNAD technology and Pre-Treatment devices, will eventually cover the whole area of health, life-sciences and environment including the oil-industry, fish farms, primary health prevention and complex waters
Main Dissemination Activities:
Contacts were established with the main embassies and representatives from Kenya, Uganda, Rwanda, Ghana and DR Congo at the NABA (Norwegian African Business Association) Nordic business summit in OSLO, Norway November 2015. They showed great interest for the selfPOCNAD technology with several local distributors, hospitals and business women indicating their desire to start screening 10 000 women every year using this technology.
The new METIS 4.0 platform that will be used for the selfPOCNAD high volume production line was presented at Motek trade fair in Germany. A blog article was posted on the company website to further promote the new development that is well suited to the production of SelfPOCNAD and other medical devices.
The POCNAD technology was presented at the MicroTAS conference in Freiburg October 2013, Germany, at the main exhibition under the Norwegian Center of Expertise, Micro and Nanotehnology.
Case Study Information
We have developed a number of case studies which have been published in flyers, brochures and posters for use at various exhibitions. A banner based on the case study has also been designed and made available for use at various exhibitions.
Description of Significant Results Obtained:
• Agreement on IPR holding model
• A further patent application has been made on Device and Method for Refining Particles that is directly relevant to Self POCNAD DEMO project
• The health person or expert involved went through the whole technology including how clinical sample were tested and how the hardware was produced
• The POCNAD instruments and cartridge were demonstrated in front of the primary health expert and he reported satisfactory results following the given claims
• Roadmap established for the production of selfPOCNAD instrument and cartridge products
• Important feedback gathered at trade fair for further development of METIS platform.
• Six scientific papers submitted and/or awaiting peer review.
• Over thirty significant dissemination activities completed
• Significant Interest in selfPOCNAD technology in Kenya, Uganda, Rwanda, Ghana and DR Congo
• Wettre and Sørbye study indicates that selfPOCNAD may be the preferred technology for the same day diagnosis and treatment
• Blatt et al compared cervical cancer screening confirm that self POCNAD should be used as the medical gold standard
• selPOCNAD product disseminated internationally including Congo, Sri-Lanka, South Africa and USA

List of Websites:
The address of the web-site is: http://www.selfpocnad.eu/. On accessing the website, the website’s public area pages containing non-confidential information can be viewed. Link to the original research web site has been maintained (http://res.selfpocnad.eu/)

Informazioni correlate

Contatto

Morten Hagen, (CFO)
Tel.: +47 32798800
Fax: +47 32798801
E-mail
Numero di registrazione: 184724 / Ultimo aggiornamento: 2016-06-27