Community Research and Development Information Service - CORDIS


intime Report Summary

Project ID: 666852

Periodic Reporting for period 1 - intime (Prototyping 'intime' - a NINAAT-based self testing platform to detect infectious diseases)

Reporting period: 2015-04-01 to 2015-09-30

Summary of the context and overall objectives of the project

In Q1 and Q2, SelfD Technologie GmbH and its project partners have further specified technical requirements, handling and validation procedures. Among others, we have embarked on the establishment of a comprehensive Quality Management System and a Risk Management System following ISO 13485 and ISO 149771, respectively. In addition, we have completed the design phase for the multifunctional prototype and set up a powerful project management.

In line with our objective to develop a multifunctional test device we have specified all relevant technical and commercial requirements. For example, the consortium has designed methods to detect one or various pathogenic targets simultaneously. Such modular design will eventually allow us to offer both singleplex and multiplex tests in accordance with market needs.

The targeted improvement of health conditions across the globe requires the design of a fast and highly accurate test that can be used at the point-of-care (POC). During the first reporting period, SelfD has developed a molecular assay that fulfills all requirements outlined in the DoA. The evaluated performance assures a completed amplification reaction within 25 min enabling users to perform the test in half an hour. Furthermore, the assay - whose accuracy lies at 95% - was incorporated in a functional model allowing highly accurate testing. The detection of CT-infections at the POC will contribute to a faster therapeutic treatment thus helping to reduce the spread of the disease and the associated costs, respectively.

The design of the prototype will reflect our ambition to develop a small and disposable device that uses the power of nucleic acid amplification. For example, SelfD’s work conducted during Q1 and Q2 to ensure disposability was strongly linked to the design of a heater and the internal power supply. Further specification of the heater’s and the power supply’s integration into the test will help us to develop a self-contained device that can be used by untrained individuals regardless of external power supplies or separate, cost-intensive instruments. In addition, the ease-of use will be enhanced by the use of urine as sample material.

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

To ensure a timely and focused completion of the H2020 project “intime”, the consortium has designed a comprehensive project plan that includes all relevant tasks and subprojects for partners and subcontractors. The project started on 1 April 2015.

As outlined in the DoA, work package 1 included a comprehensive definition and documentation of all relevant specifications. Among others, SelfD has reviewed thoroughly the target specifications of the intime CT-test and the intime CT/NG/TV-test; such review included discussions and negotiations with project partners as well as subcontractors. Marketing and Sales has revised all user and market requirements. In addition, product specifications were detailed and the competitive environment was studied carefully. Furthermore, Marketing and Sales has researched price and revenue conditions within the target market. Based on first negotiations with manufacturers, the department has also set target costs for production.

Research and development has set the technical requirements and fixed possible limitations for the upcoming prototyping phase. The technical requirements were outlined for each unit of the product including sample preparation, amplification and detection, differentiating between the molecular assay and the device where appropriate. In addition, we have reviewed the targeted performance specifications for both the singleplex and multiplex test. The clinical study coordinator has evaluated thoroughly the required clinical studies with regard to safety, effectiveness and usability.

Work package 2 is dedicated to the design of the multifunctional prototype, among others. As outlined in the DoA, the design phase was finalised in Q2 and will be followed by the rapid prototyping. The design transfer from the functional model to the prototype required the inclusion of experienced consultancy by different subcontractors and partners such as Talleyrand Consulting, Little Things Factory, Bioatlas, all holding a long-standing expertise in their specific sectors. Such cooperative approach helped us outline precise requirements for all major parts of the product.

The performance evaluation of the multifunctional test device, as described in work package 3, includes the cultivation of pathogens and the establishment of handling procedures of for the validation. In order to determine performance parameters such as the limit of detection and possible interferences, we have been working during the first reporting phase on a wide range of issues. For example, we have conducted thorough culturing and storage strategies for CT, NG and TV. Also, the established culturing method of CT within a human host cell line was fixed within a standard operating procedure (SOP) and various ways to quantify NG and TV pathogens were studied including real-time PCR, flow-cytometric strategies and microscopic quantification.

Work package 4 is composed of three tasks. 4.1 is dedicated to the establishment and the certification of a Quality Management System (QMS) according to ISO 13485. Here, we have finalised the QM-process for planning and strategy. The process defines the main procedures, assigns responsibilities and determines the company’s strategy on resources, products and budgeting. Also, we have established the QM-development process – a framework that paves the way towards the prototype. The outlined procedures ensure the developed product will meet all market requirements and customer expectations. The QM-process for product approval is currently being outlined. The document will define the procedure towards product certification and describes all regulatory requirements for the technical documentation. Prior to establish the QM-process for performance evaluation, we have analysed the procedures of the preceding analytical and clinical performance checks. Such preceding evaluations were conducted to assess the performance of the molecular assay outside the device. They will for

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)

This project marks the first time a fully non-instrumented DNA amplification test is realized as a small hand held device that can be used at the point of care (POC). Combining the best of laboratory technologies accuracy and the portability and low cost of a disposable device, ‘intime’ will help detect diseases at an early stage thus contributing to a substantial reduction in healthcare spendings and – equally important - to an improvement of living conditions across the planet.

SelfD Technologie will introduce a game changing product to the market by utilizing the power of nucleic acid amplification test (NAAT) methods. The ‘intime’ project will enable us to provide a test device that is capable of detecting up to three pathogens simultaneously. Our test will require no previous training and uses only urine as an input medium. The nucleic acid amplification reaction will allow us to miniaturize the testing without the need to sacrifice sensitivity or specificity. Not only is this technique robust and sensitive, it can deliver results within 25 minutes and thus allows real diagnostics at the point of care.

Our platform is less complex, faster and more discreet than comparable platforms such as PCR. Moreover, it is significantly more sensitive, specific and user friendly than other serological platforms. Although there are several microfluidic PCR tests for POC use available, they still require the involvement of a technician and cannot be performed by end users. Also, they are usually composed of expensive non-disposable apparatus. In comparison to that, SelfD Technologie’s broadly applicable NINAAT-platform enables users to fully dispose our POC test devices.

‘intime’ will provide a compelling selling proposition and offers substantial advantages:
- The tests ensure ease of use as they do not require complex instrumentation or assistance.
- They will be instantly available, discreet, quick and affordable.
- The accuracy provided by our NINAAT-based platform is substantially higher than that of other available home tests.
- In the future, quick home tests by the SelfD Technologie GmbH will enable doctors and patients to detect various pathogens simultaneously.

Regardless of the detected pathogen, patients will benefit from the increased privacy of taking the test in the comfort of their own home without sacrificing any specificity or sensitivity of the test. Meanwhile, medical workers can benefit from the shortened time of the assay and the lower costs when compared to laboratory testing. Private doctors can also benefit from being able to reimburse the test themselves. What is more important, ‘intime’ provides them with reliable diagnosis half an hour – a substantial advantage over lengthy tests that are performed in laboratories.

Through the validation work undertaken during this project the product will be ready for launch in 2018. Market launch will start out with a device for the diagnosis of the sexually transmitted infection (STI) Chlamydia trachomatis (CT) followed by a multifunctional device including the additional pathogens Neisseria gonorrhoeae and Trichomonas vaginalis.

If left untreated, STI can cause infertility, chronic diseases and even cancer. Early detection will therefore improve healthcare across the globe as it allows preemptive screening and a faster therapeutic treatment. Our test devices will also help ease the financial burden of disease posed by STIs through highly accurate and quick testing at the Point-of-Care (POC). For example, infections with CT account for 50% of all cases of infertility. Once established, ‘intime’ will help reduce European-wide expenditures on complicated and lengthy fertility treatments substantially. The annual cost in the member states of the European Union are currently EUR 3 billion.

In other words: The mission, vision and purpose of SelfD Technologie have been carried forward by a global paradigm shift in healthcare. With growing pre

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Record Number: 186329 / Last updated on: 2016-07-11