NEW YORK – A new multicenter study set to begin in Italy this year will evaluate Swedish diagnostic company Gradientech's rapid antibiotic susceptibility testing (AST) system and inform rapid AST policy and recommendations in the country.
Run by A.D.A., Gradientech's exclusive distributor in Italy, in collaboration with the Italian Society for Clinical Microbiology (AMCLI), the study will be run at four hospitals with microbiology laboratories in Italy's Lombardy region. It will compare Gradientech's QuickMIC rapid AST system with AST platforms currently in use in those hospitals, including BioMérieux's Vitek and Beckman Coulter Diagnostics' MicroScan, as well as the gold standard reference method of broth microdilution, said Pietro Lombardi, A.D.A.'s scientific director.
One of the goals of the study, Lombardi said, is to evaluate the performance of QuickMIC in comparison to other commercially available systems while also establishing how to use rapid AST systems like QuickMIC accurately. Hospitals that want to introduce these new technologies "need to establish in advance … the most accurate ways" to use them and must "demonstrate … the potential impact of these technologies in [terms of] a patient's survival," he said, particularly considering hospitals' constrained budgets.
The study will be under AMCLI's control, and all four centers will act independently, Lombardi noted, so the results will have "a much deeper value" than a study conducted entirely under the company's control.
Each hospital will test at least 50 samples from hospitalized patients with both the QuickMIC system and whatever commercially available system is already present in the laboratory, and the majority of samples will also be tested with broth microdilution. The results will be compared across all three methods and will be evaluated for performance and accuracy as well as the impact on patients of having results in two to four hours with QuickMIC versus the longer turnaround times of commercially available systems, Lombardi said.
The study will evaluate "the impact of these technologies [on the] clinicians' behavior in terms of therapy management and patients' survival," he added.
The QuickMIC system uses microfluidic technology and applies agarose gels embedded with the bacteria of interest and treated with different antibiotic concentrations. It then utilizes automated microscopy to monitor the gels for microcolony growth and returns results in two to four hours.
Currently, the hospitals are preparing to install the QuickMIC systems, which is expected to finish by the end of April. Lombardi said the study's results are expected to come out in about six months.
QuickMIC uptake
Gradientech CEO Sara Thorslund said that she hopes the study's results will leave AMCLI confident in the QuickMIC system and that the rapid AST best practice recommendations put in place by AMCLI after the study will have a commercial benefit for the company.
The QuickMIC platform received CE marking in 2022 along with a Gram-negative panel and has been implemented in routine clinical diagnostics in hospitals in Germany, Italy, Romania, and Bosnia, she noted. It also has distribution deals with partners in a variety of other European countries, including the UK and Ireland, Portugal, Austria, Switzerland, Eastern Europe, the Baltics, and the Nordics. Right now, the firm is focused on increasing the installed base of its instruments and adding more hospitals to its customer base in Europe while also working on regulatory clearance in the US, Thorslund said.
Uppsala, Sweden-based Gradientech has partnered with Hardy Diagnostics in the US and Canada and is currently running clinical studies with three undisclosed US hospitals that will be used to seek clearance from the US Food and Drug Administration, with 510(k) submissions for the platform and a Gram-negative panel expected later this year. The QuickMIC system received breakthrough device designation from the FDA in 2023.
Gradientech also announced last year that Hardy Diagnostics would invest an undisclosed amount in the firm and would become one of Gradientech's largest shareholders. Hardy provides microbiology products throughout North America.
Thorslund noted that the Gram-negative panel has been slightly changed for the US market due to which antibiotics are most prevalent in each market and differences in how rapid AST diagnostics are used. In the US, rapid AST diagnostics are often used to de-escalate to move treatment to more narrow-spectrum antibiotics, while in Europe they are usually used to escalate treatment.
Gradientech is also working on a second Gram-negative panel for the European market that will include so-called last resort antibiotics, she said. Such antibiotics are used when other common antibiotics are ineffective as treatments.
"We'll have market-specific panels in the long term," she added.
The firm is competing against multiple other US and European companies within the rapid AST market as well. US-based firms like Selux Diagnostics and Pattern Bioscience are smaller but have raised millions of dollars to commercialize their rapid AST systems, while European microbiology giant BioMérieux received FDA approval for its Vitek Reveal rapid AST system last year. Meantime, Accelerate Diagnostics is in the process of commercializing its new Wave platform for rapid AST and intends to capitalize on its existing customer base. However, all four firms have systems with a longer time-to-result than the QuickMIC platform, which could provide a significant competitive advantage.
The company is also in the final stages of getting certification for its test under Europe's In Vitro Diagnostic Regulation and expects certification in the coming months. The QuickMIC system gained compliance under IVDR in 2022.
In addition to the new Gram-negative panels, the firm also plans to launch a version of the QuickMIC system with an integrated screen in 2025, so an external computer will not be required to run the system. This will "further reduce the footprint of the system" and allow Gradientech to offer a "complete solution," Thorslund added.