Bacteromic, a subsidiary of the Warsaw Stock Exchange-listed Scope Fluidics Group, has signed an agreement with COMAC Medical to conduct clinical trials of the BACTEROMIC system PBC Panel. The trial schedule is consistent with the anticipated timeline for obtaining IVDR certification for the PBC Panel in 2027.
“We are consistently progressing through the successive stages of our flagship BACTEROMIC project. Our objective is to provide laboratories and physicians with a comprehensive solution ensuring the rapid and precise diagnosis of bloodstream infections, and the commencement of clinical trials for another panel represents an important step toward achieving this objective. The work schedule is progressing as planned and brings us closer to obtaining CE-IVDR certification in 2027 and introducing further elements of our technology to the market, while also strengthening its value and commercial potential,” says Piotr Garstecki, CEO of Scope Fluidics.
The clinical trials are one of the key elements of the process of obtaining a CE-IVDR certificate confirming that the BACTEROMIC system with the PBC Panel complies with the requirements of the In Vitro Diagnostic Medical Devices Regulation.
As planned, IVDR certification of the BACTEROMIC system with the PBC Panel will be carried out with the participation of the notified body that issued the IVDR certificates for the BACTEROMIC system with the UNI Panel and the UNI FAST Panel earlier this year. The other components of the BACTEROMIC system, namely the interpreter, analyzer and filling unit, have already obtained IVDR certification.
The total estimated cost of conducting the trials should not exceed EUR 1 million.
