Miacom Diagnostics and MetaSystems: First Ultra-Rapid Phenotypic MRSA/MSSA Differentiation Assay

As a joint effort, Miacom Diagnostics GmbH and MetaSystems GmbH announced the development of an ultra-rapid super bug assay that allows the 30 minute differentiation of multiple resistant strains (MRSA) and normal, sensitive strains (MSSA) of the clinically most prominent pathogen S. aureus directly from samples without need for sample preparation or costly target amplification. The assay has now entered the clinical trial phase and will be introduced to the European market to offer a novel solution to physicians to initiate proper antibiotic treatment to patients suffering from a hospital acquired infection such as sepsis or pneumonia. For the first time, it doesn´t detect genetic mutations responsible for resistance but instead shows a resistant phenotype of the organism. As there are frequently new mutations observed, this approach is independent of new genetic variations of resistant strains as the outcome of such mutations will always result in the same phenotypic variations, giving this approach a great advantage over the existing PCR based approaches.

The new assay follows the path MetaSystems and Miacom Diagnostics have chosen and will be initially available to be used on the Metafer RPI Platform allowing an automated, high-throughput slide analysis directly after the samples are prepared using Miacom’s standard Direct Multiplex Imaging procedure. The MRSA/MSSA differentiation will be available as either a stand-alone assay for screening species of Staphyloccus for MRSA or as a combined multiplex assay detecting more than 10 important Gram positive and Gram negative bacteria in a sepsis. As all of miacom’s assays, this assay relies on the FDA-approved Direct Multiplex Imaging (DMI) technology which allows to test patient materials directly without the need for amplification in a multiplex fashion differentiating up to 14 pathogens in one single test. The identification of the bacterial strains is made possible via detection of fluorescent light given by the molecular probes used when they find their specific target molecules.

The launch of this addition to Miacom’s existing test kits is expected to take place in 2017 and will offer physicians to improve their treatment strategies. ”In the long run this will result in the reduction of the use of broadband antibiotics, reduce patient morbidity and mortality and also help clinics to save time and resources”, stated Dr. Mirko Stange, CEO Miacom Diagnostics.