Mobile diagnostic systems for social diseases (MEDIKIT)

The background

Social diseases such as cancer and cardiovascular diseases are major health threats. From 2011 to 2016, every fourth citizen of the European Union died of cancer or heart disease. An early and reliable diagnosis of the diseases increases the chances for a successful therapy of these diseases.

The analysis system

MEDIKIT is a mobile, decentralized and quantitatively evaluable diagnostic platform that enables individual diagnostics and research into therapeutic measures. In addition to the development of the analysis platform, Senova will also develop novel sensitive detection methods for marker proteins. In comparison to previous point-of-care tests placed on the market, these enable the detection of very low concentrations of biomarkers. This makes it possible to detect cancer or heart diseases early and safely. The MEDIKIT is to be placed on the IVD market after the end of the project. In addition, the technology promises to develop further very sensitive evidence for the POC application.

The consortium

In addition to the development of highly sensitive detection systems, the development of reliable and inexpensive sensors as well as optimized liquid handling of the samples is required. Through the development of complex biological-microelectronic sensor interfaces, these components enable the development of the entire diagnostic platform. In addition to the immunological detection methods, sensitive detection methods for free circulating tumor DNAs are to be established on the platform. The joint project is therefore carried out by Senova together with the Institute for Microelectronics and Mechatronic Systems (IMMS), as well as the companies oncgnostics GmbH and ALS.

Project partners: IMMS GmbH
Ehrenbergstrasse 27
98693 Ilmenau
  ALS Automated Lab Solutions GmbH
Otto-Eppenstein-Stra├če 30  07745 Jena
  oncgnostics GmbH
Winzerlaer Str. 2, 07745 Jena

The project, funded by the Free State of Thuringia, was co-financed by the European Union within the framework of the European Regional Development Fund (ERDF).

Up-converting-phosphorescence (UCP) technology-based lateral flow assays for the highly sensitive detection of the cardiac marker proBNP (natriurietic peptide type B) (UP-TAB)

In the next generation diagnostic market, some fundamental properties of lateral flow tests should be improved. The top priority is to improve precision and sensitivity. The existing up-converting-phosphorescence (UCP) particles allow a very sensitive detection in comparison to conventional fluorescence particles. However, the UCP particles cannot be used for an application in the lateral flow format. As part of this project, UCP particles for the LFA format are to be made accessible to enable highly sensitive detection of proBNT. In addition, it is essential to develop a suitable and inexpensive analysis system with which the fluorescence intensities of the test lines can be quantified. By combining the UCP technology and the LFA technology, POCT can be obtained with the performance of the laboratory machines.

The cardiac marker proBNP

A heart defect caused by cardiac dysfunction is currently one of the biggest health problems with high mortality rates. The success of a therapy measure depends largely on the time of diagnosis. The N-terminal fragment of the B-type natriuretic peptide BNP (NT-proBNP) is a very reliable biomarker for the diagnosis of a heart defect. Two methods are currently used to determine the NT-proBNT concentration. An electrochemiluminescence-based laboratory device from Roche (Elecsys® NT-proBNP II) and a fully automated biochemistry-based analyzer (Dade-Behring Dimension RXL). Both reliably determine the NT-proBNT with assay times of ~ 2 h. POCT methods are also available on the market, using a wide variety of technologies such as lateral flow assays, microfluidic systems or turbidimetry. The detection is carried out promptly, but the sensitivity is very low, which leads to false negative results.

The project, funded by the Free State of Thuringia, was co-financed by the European Union within the framework of the European Regional Development Fund (ERDF).