Bacteromic sp. z o.o., a member of the Scope Fluidics group developing innovative medical diagnostic devices, has signed a manufacturing agreement under which, together with its business partner Technicolor, it will develop a small-scale cartridge manufacturing line for the BacterOMIC system and conduct R&D activities. The state-of-the-art device, developed by the Polish team, is the first in the world to provide quantitative assessment of bacterial susceptibility to a wide range of antibiotics in a single test.
The manufacturing line for the BacterOMIC system will be developed by Technicolor Precision BioDevices (Technicolor Poland), a member of the international Technicolor group, based on the know-how of the Scope Fluidics Group. The agreement has been signed for one year and is a pilot project. The parties, within the framework of R&D activities, will cooperate not only on the development of a small-scale manufacturing line, but also, among others, on optimizing the cost of manufacturing cartridges.
“This is an important factor in building the market value of both the BacterOMIC system and the company itself. During the term of the agreement, we also intend to negotiate the terms of our potential cooperation in large-scale cartridge manufacturing. We believe that in this way we will better prepare Bacteromic for the market,” says Marcin Izydorzak, Member of the Board of Scope Fluidics S.A.
David Holliday, President of Technicolor HES commented “Technicolor is a world leading provider of precision manufacturing and related supply chain services with a long legacy of serving media and entertainment customers, as well as an expanding presence in the medical diagnostic and life science markets under the Technicolor Precision BioDevices tradename. Technicolor will be supporting manufacturing of the BacterOMIC cartridges from its existing production facility in Piaseczno, Poland. We’re very pleased to be collaborating with Scope Fluidics Group for this pilot manufacturing phase.”
The BacterOMIC system is currently being tested in three independent external laboratories. The aim of the trials is to assess the system’s performance, especially including the correctness of analyses using a panel that allows quantitative determination of drug susceptibility to antibiotics administered in the treatment of gram-negative and gram-positive bacterial infections. A positive result of trials in clinical centers will constitute the grounds for applying for a CE IVD certificate, which will open way to the introduction of the diagnostic device to the European market. The CE IVD certificate is planned to be obtained this autumn.
Works on the system began in 2016 – at that time the general assumptions were specified, which were developed in subsequent stages by the Scope Fluidics Group team. Subsequent generations of the system, with improved ergonomics and solutions to facilitate industrialization, were tested in prestigious clinical centers, including the National Medicines Institute, the National Tuberculosis and Lung Diseases Research Institute and the Children’s Memorial Health Institute in Warsaw.