Funded projects

Over the years many funding organisations, academic organisations as well as private companies and VCs have had confidence to support our idea of bringing the only painless multitest to detect STDs. All the support has enabled us to bring the simple idea to a Nobel Prize winning technology and product. Here, we will draw your attention to the most important research projects, which have been carried out during the different phases of product development.

The following list describes the most important projects funded (in chronological order):

0.21 M EUR

in total

Project: Development of the core technology of the STD Multitets CT / NG in a pilot line for mass production (KET-STD Multiplex CT/NG, KET Pilotlinie zur Massenproduktion)


0.79 M EUR
Project duration:
01.07.2019-31.12.2021

English:
The goal of Selfdiagnostics Deutschland GmbH is to transfer the key technology for the production of the STD Multitest CT/NG to the Leipzig production facility in a pilot line. The key component is a microfluidic core chip with integrated molecular components for amplification and detection of target nucleic acids. The pilot line will enable mass production of the reagent pellets and their integration into the core chip. In a first step, the design of the core chip and the interfaces to the housing will be adapted. By optimizing and automating the production processes of the core chip and its reagents, the capacity will be increased and production costs reduced.
With the establishment of this pilot line, Selfdiagnostics Deutschland GmbH in Leipzig expands its position as a development and distribution company into a manufacturing company and concentrates its core know-how at one location.

German:
Das Ziel der Selfdiagnostics Deutschland GmbH ist es, in einer Pilotlinie die Schlüsseltechnologie zur Produktion des STD Multitests CT/NG in die Leipziger Produktionsstätte zu überführen. Die Schlüsselkomponente ist ein mikrofluidischer Kernchip mit integrierten molekularen Komponenten zur Amplifikation und Detektion von Ziel-Nukleinsäuren. Die Pilotlinie soll eine massentaugliche Produktion der Reagenzien-Pellets und deren Integration in den Kernchip ermöglichen. Dazu werden in einem ersten Schritt das Design des Kernchips und die Schnittstellen zum Gehäuse angepasst. Durch Optimierung und Automatisierung der Herstellungsprozesse des Kernchips und seiner Reagenzien werden die Kapazität gesteigert und die Produktionskosten gesenkt.
Mit dem Aufbau dieser Pilotlinie erweitert Selfdiagnostics Deutschland GmbH in Leipzig seine Position als Entwicklungs- und Distributionsunternehmen hin zu einem produzierenden Unternehmen und konzentriert sein Kern-Knowhow an einem Standort.

Funding organisation: Sächsische AufbauBank – Förderbank. Project is supported by European Regional Development Fund

Project: Development of inhibitor tolerant DNA polymerase for application in isothermal amplification directly from unprocessed samples (eg blood, urine, soil, nasal swab) for application in (point-of-care) diagnostics of infectious diseases.


0.3 M EUR
Project duration:
01.08.2017- 31.07.2020

The aim of the project is to develop a novel DNA polymerase applicable for nucleic acid isothermal amplification methods that are used in a field of molecular diagnostics. The DNA polymerase which is developed during the project is a part of the development of first and unique molecular diagnostics based device, which helps to detect diseases and provides diagnosis at home. The product will deliver results that are comparable with sensitivity and specificity of gold standard laboratory techniques such as PCR.

Selfdiagnostics works collaboratively with the University of Tartu on applied research in smart specialisation growth areas. The created know-how enables a long term collaboration with academic institutions.

Funding organisation: Archimedes. Project is supported by European Regional Development Fund

Project: Prototyping the NINAAT based point-of-care device for the detection of infectious diseases


0.35 M EUR
Project duration:
02.05.2017- 30.04.2018

The objective of this project is to develop a molecular diagnostic based Point of Care (PoC) device prototype for detection of infectious diseases. More precisely, the project aims are to further develop and adapt key components of the device – including bioassay, microfluidic core chip, micro-heater and optical readout. Aiming to integrate key components without loss of functionality. The final prototype will be tested with samples containing pathogenic target material.

Selfdiagnostics is partnering with the ELIKO Competence Center on Internet of Things driven industrial R&D program (EU48693).

Funding organisation: Enterprise Estonia. Project is supported by European Regional Development Fund

Project: Prototyping ‘intime’ – a NINAAT-based self-testing platform to detect infectious diseases.


0.52 M EUR
Project duration:
01.04.2015-30.03.2018

In parallel with the development of HomeCare diagnostics system project, we started preparations to identify the specifications for prototyping. The projects target is to bring the first non-instrumented nucleic acid amplification test device onto the market. The aim is to bring the modular ‘intime’ homecare diagnostic test from a functional model to the final prototype that is ready to be produced and brought to market. The prototype will then be made into small series production for a thorough analytical and clinical validation that will allow SelfDiagnostics to apply for the CE mark, and introduce the product shortly after the end of the project.

European Union’s Horizon 2020 research and innovation programme (SME Instrument). Grant agreement No 666852

Project: SmartFilter: Conception, development, test and validation of a novel smart filter for integration into a home care test for the detection of Chlamydia trachomatis.


0.23 M EUR
Project duration:
01.04.2015-31.05.2017

The project aim is to create an enrichment strategy for sample material differing from the SAB-project approach by developing an innovative filter design (smart-Filter) applicable in a future HomeCare product.
The underlying goal of the smart-Filter design was a sensitivity improvement in a future product to achieve performance-wise complete comparability with routine laboratory tests and to add in comparison to routine laboratory technologies a level of handling-simplicity usable for lay persons.

Funding organisation: Federal Ministry of Economics and Energy, ZIM-kooperationsprojekte

Project: Development of a multiplexed HomeCare diagnostic system for the detection of sexually transmitted pathogens.


0.47 M EUR
Project duration:
01.12.2014-30.11.2017

The project aim is the development of a “Home care diagnostics system” multifunctional test platform ready for prototyping. The specific project goals are to develop molecular and technical multiplexed test design with internal control system and lateral flow detection system; to develop amplification reactions for multiplexable target pathogens and to unify lysis method for the project targeted pathogens, and finally to enrich target DNA-material for application into HomeCare test system. The aim is to establish the multiplex of the test platform ready for prototyping, which entails considerable potential in order to realise various combinations of excitatory panels within the product group of the STI-proofs. It enables to open up totally new range of product combinations and widens the product groups in the future.

Funding organisation: Sächsische AufbauBank – Förderbank, European Regional Development Fund

Project: Development of an innovative nucleic acid-based HomeCare diagnostic system for the detection of sexually transmitted pathogens.


0.73 M EUR
Project duration:
15.04.2013-30.11.2014

Sub-project: Development of a NAAT-nucleic acid amplification technology as a POCT rapid test on Chlamydia trachomatis and Mycoplasma genitalium in for home use.

It is a follow-up project with an aim to confirm the data gathered in the first project in 2010. The outcome of the project was a simple diagnostic test system (assays) for the detection of STI pathogens (C.trachomatis and M.genitalium) in urine.

Funding organisation: Sächsische AufbauBank – Förderbank, European Regional Development Fund

Project: Medical Rapid tests


0.82 M EUR
Project duration:
01.04.2010-31.05.2013

The aim of the project was to identify suitable amplification methods ready to be integrated and tested in a test platform. The outcome of the project is the RPA based three-stage platform for the detection of C.Trachomatis directly from unprocessed urine. During the project first clinical validation was done and relevant information gathered to have an input for further developments in the field.

Funding organisation: Enterprise Estonia, European Regional Development Fund

During open innovation technology development SelfDiagnostics is or has been collaborating with many academic institutions in Europe – University of Tartu, Fraunhofer Institute for Cell Therapy and Immunology (IZI), Tallinn University of Technology, Dresden University of Technology, Institute for Bioprocessing and Analytical Measurement Techniques, and with many companies in Europe (in Estonia, Germany, United Kingdom) and in US and Asia.

For more information please contact :
Project coordinator – Reilika Paas

reilika.paas[at]selfdiagnostics.eu
Skype:reilika777