NEW YORK ─ Gradientech on Tuesday announced it has obtained the CE mark for the QuickMIC system and Gram-negative panel for the antibiotic susceptibility testing (AST) of samples from sepsis patients.
With CE marking and "successful results" from a recent clinical study, "the QuickMIC system is now ready for the European market," Gradientech CEO Sara Thorslund said in a statement.
The Uppsala, Sweden-based firm said the QuickMIC system's rapid and precise results enable sepsis patients to quickly receive personalized guidance and obtain the correct antibiotics at the correct dose. Its modular design allows hospitals to start on a small scale and scale up as needed by adding more instruments, the firm added.
The QuickMIC system and panel, Gradientech's first diagnostic product, uses microfluidic technology, applying agarose gels that are embedded with the bacteria of interest and treated with different antibiotic concentrations. The system uses automated microscopy to monitor the gels for microcolony growth.