Community Research and Development Information Service - CORDIS

H2020

intime Report Summary

Project ID: 666852

Periodic Reporting for period 3 - intime (Prototyping 'intime' - a NINAAT-based self testing platform to detect infectious diseases)

Reporting period: 2016-04-01 to 2016-09-30

Summary of the context and overall objectives of the project

SelfDiagnostics will introduce a game changing product to the market by utilizing the power of nucleic acid amplification test (NAAT) methods. ‘intime’ 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 30 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. 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 can't be performed by end users. They are usually composed of expensive non-disposable apparatus. In comparison to that, SelfDiagnostics’ broadly applicable NINAAT-platform enables users to fully dispose our POC test devices.
Applications beyond STI are diverse. Our NINAAT-platform is unique and broadly applicable in healthcare, veterinary, agriculture, food and the environmental industry to detect contamination, genetic disorder or pollution. Potential customers include food companies, farmers’ associations and public institutions.

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

In Q5 and Q6 the ‘intime’ team has finalized the validation plan and submitted the related deliverable 1.2. It outlines a usability study and describes comprehensively the analytical and clinical performance evaluation.
SelfDiagnostics has received the prototypes of module A and B including the sample plug from Thinxxs. The results of the successful tests were described in D2.2. Tested functionalities include the liquid flow, the self-regulating heater, functional LAMP reactions and the positioning of the sample plug. Module C – supplied by Thinxxs in September - covers all functionalities including the blister. Essential interface functionalities of the preliminary tested housing and the inner corechip are under construction and will be tested in near future. After completion of this final testing phase the corechip and the housing design will be frozen.
Our team has dedicated an essential part of the prototyping work to the application of the stabilized amplification reagents. Bioatlas has been providing reagent-pellets for the prototyping phase. The company has enabled SelfDiagnostics to prepare reagent pellets for testing in-house as well by a technology transfer. Optimization of production and handling processes for the lyophilisation of reagents on the selected plugs is ongoing to ensure certifiable production processes. This includes the completed characterization of pellets by freeze drying microscopy and the testing of pellets derived and stored in differing environments (e.g. varying humidity levels and packaging requirements).
During Q5 and Q6 we have also evaluated the cultivation and quantification measures for Chlamydia trachomatis (WP 3). The pros and cons of the available methods were weighed prior to the decision about their implementation for the analytical performance tests. The team has continued to work on an efficient pretreatment solution to increase sensitivity by stabilizing DNA and reducing inhibitory effects of urine samples. Further studies are conducted for Neisseria gonorrhoeae and Trichomonas vaginalis preparing future analytical performance tests. Further procedures such as the handling of the testing-panels for potential cross-reacting organisms and interfering substances are nearly completed.
In Q5 and Q6 we have continued to work on the establishment of a Quality Management System (QMS) in compliance with ISO 13485 (WP 4). The ‘intime’ team has started to implement a series of new processes, e.g. communication, product requirements and staff training. We met with our suppliers to discuss their manufacturing process and clarify quality related issues like outgoing good control. SelfDiagnostics started to implement risk reducing actions that resulted from the risk analysis of the product to assure patient safety. Here, we designed mitigating actions such as preclinical tests and the establishments of SOPs. Our next steps include the creation of a comprehensive risk analysis for all manufacturing processes. Determined actions will be transferred into the validation of the production process and the equipment needed. SelfDiagnostics will perform a risk analysis on work environments. SelfDiagnostics has followed and fulfilled the implemented project plan. This includes the submission of deliverables and the coordination of our project work with all involved partners. Among others, the preliminary testing of the multifunctional prototype (D2.2, M2) was successfully completed. Our project manager has coordinated the completion of the validation plan (D1.2) the marketing and distribution plan (D5.3) as well as the plan for the use and dissemination of foreground (D5.4). The FTO analysis was continuously analyzed and is close to completion (D5.2 and M7). We have also continued to establish quality agreements (QAA) with our partners to ensure the design for small series production can be frozen on time.
With respect to WP 5 we have continued to outline the patenting strategy together with the Danish patent office. Regular reviews confirmed that neither SelfDiagnostics nor our partners violate any third parties’ rights. We have updated a previously conducted survey on SelfDiagnostics’ competitive environment and designed a powerful communication strategy. An advisory board will provide strategic recommendations, a cooperation with the Germany-based consulting company BCNP helps us gain valuable insight into market forces, distribution networks and user expectations.

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)

As one of Europe’s most ambitious medical research and development companies, SelfDiagnostics holds a unique technology for medical devices that helps detect diseases and provides diagnosis at home. ‘intime’ will help us pave the way to develop a prototype and launch our first test in the foreseeable future. Previous research for this novel and innovative medical diagnostic device has laid the foundation for a successful completion of the prototyping and the clinical as well as analytical evaluation of the performance to qualify for the CE marking and FDA approval. Both steps are key to a successful market launch and subject
to this application.
This business innovation 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. SelfDiagnostics will launch its multiplex quick home tests in a dynamic market environment; starting in 2018 with a first test on CT. The company’s portfolio will then be gradually expanded by other STI-pathogens, e.g. by NG and TV during the year 2019. Quick home tests on pathogens beyond STI (such as Malaria or Influenza) will be launched from 2022 onwards.
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.

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