NEW YORK – Gradientech said Tuesday that Hardy Diagnostics will distribute its QuickMIC antibiotic susceptibility testing system in the US and Canada and is becoming an investor of the Swedish company.
Hardy Diagnostics will invest an undisclosed amount in Uppsala-based Gradientech and become one of the firm's largest shareholders.
"With QuickMIC already being implemented in several European hospitals and the 510(k) study of QuickMIC recently started at clinical sites in the US, the important North American market is a key focus for us," Gradientech CEO Sara Thorslund said in a statement.
Hardy Diagnostics provides microbiology products throughout North America and will be the exclusive distributor of QuickMIC in the US and Canada. The system utilizes microfluidic technology and applies agarose gels embedded with the bacteria of interest and treated with different antibiotic concentrations. It uses automated microscopy to monitor the gels for microcolony growth and returns results in less than two hours.
Gradientech received CE marking for the QuickMIC system and Gram-negative panel in 2022 and gained compliance with the EU's In Vitro Diagnostic Regulation later that year. Last year, the system received breakthrough device designation from the US Food and Drug Administration.
The company has inked distribution agreements for QuickMIC with partners in the UK and Ireland, Portugal, Italy, Austria, Switzerland, Central Eastern Europe, Sweden, Denmark, Norway, Iceland, and the Baltics.