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

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

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 funding reference: https://www.eliko.ee/competence-centre-program/

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

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

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

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