miacom diagnostics wins national funds for novel TB test

miacom diagnostics receives government funding to develop a rapid molecular diagnostic assay for Mycobacteria species in respiratory samples

Düsseldorf, Germany May 16th 2017 – miacom diagnostics GmbH, a German diagnostics company and provider of rapid diagnostic assays to facilitate initial targeted antibiotic therapy for various infections, today announced that the company has been granted government funding by the German Federal Ministry of Education and Research (BMBF) to develop a novel molecular diagnostics (MDx) assay for the identification and differentiation of Mycobacteria. The 30 minute test will be the first IVD assay to differentiate the often deadly Mycobacteria belonging to the Mycobacterium tuberculosis complex (MTC) from the less critical Mycobacteria, not belonging to the complex (Mycobacteria Other Than Tuberculosis – MOTT) as well as from other bacteria in general.

Each year, more people die from infectious diseases than from cancer. The development of resistant pathogens is leading to an increase in fatal disease outcomes. Within infectious diseases, Tuberculosis (TB) remains one of the deadliest illnesses of the world. In 2013, globally there were about 9 million new cases of TB and 1.5 million lives were lost.

TB develops after an infection with bacteria belonging to the so-called Mycobacterium tuberculosis complex. Often slow and inaccurate test systems for the disease-causing bacteria worsen the disease outcome, as targeted and appropriate patient treatment directly depends on rapid and precise pathogen identification. According to the WHO, one third of the infections remain undiscovered, which is unfortunately a clear indicator for missing diagnostic options.

Because of their clinical importance, in terms of strategies for treatment and the epidemiological implications, a rapid differentiation of causative Mycobacteria is important. However, isolation and identification procedures usually require several weeks. In addition, most existing test systems, including skin and blood tests as well as the classical staining of patient samples, yield not only identical positive results for all Mycobacterial species but detect non critical acid fast bacilli in general. By not providing Mycobacterial species differentiation and not working directly from respiratory samples previous assays make it challenging to provide a prompt differential diagnosis and thereby fail to support proper therapy.

„With the government funding we will facilitate the development of a simple and useful method for the rapid detection and simultaneous identification of pathogenic Mycobacteria in primary clinical specimens as well as for the identification of culture isolates.“ states Dr. Walter von Stein, CSO miacom diagnostics GmbH. „Our assays is designed to close the existing gap in TB diagnostics and we look forward to contributing to the global fight against the deadly outcome of tuberculosis.“

With the approved funding, miacom will develop a novel molecular diagnostic assay for the direct identification of bacteria included in the Mycobacterium tuberculosis complex and their simultaneous differentiation from bacteria belonging to the MOTT group. The MDx will be based on miacom diagnostics“ proprietary and innovative Direct Multiplex Imaging (DMI) technology, which enables identification of specific microorganisms without prior sub-cultivation of the respiratory samples and complements existing multiplex assays for bacteria involved in sepsis and hospital-acquired pneumonia.

Keywords:miacom diagnostics, miacom, diagnostics, tuberculosis, TB, BMBF, Düsseldorf, funding, mycobacterium

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