Dutch diagnostics company Inbiome has secured the EU’s In Vitro Diagnostic Regulation (IVDR) certification for its rapid bacterial identification system.
This certification allows for the commercial deployment of the system across the European region.
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The system is designed to identify the bacteria in samples of cerebrospinal fluid, tissue biopsies, and synovial fluid. It utilises a ‘DNA barcode’ technique to detect bacterial pathogens within hours.
With the analysis of a conserved genetic area length in bacteria, the test claims to offer high specificity for detecting elusive pathogens.
Clinical studies at Amsterdam University Medical Center’s (UMC) Emma Children’s Hospital in the Netherlands have demonstrated the system’s potential to decrease the needless use of antibiotics in infants with fever.
Additionally, a study in Austria has shown a 30% additional detection rate for joint infections with previously negative culture results.
Inbiome noted that its recent Food and Drug Administration breakthrough device designation, coupled with this IVDR certification, supports its planned entry into the US market by 2026.
The company is set to expand its collaborations with labs and hospitals across Europe, supported by an upcoming funding round aimed at accelerating commercial and research and development activities.
Partnerships with Amsterdam UMC and more than 15 other hospitals in the US and Europe are underway for real-world validation trials, enhancing workflows to reduce the time to treatment.
According to the company, its Molecular Culture ID platform provides outcomes up to 20 times quicker than traditional culture methods.
Inbiome CEO Dr Dries Budding said: “This certification validates years of innovation aimed at solving one of healthcare’s most persistent challenges: diagnostic delays that endanger patients and drive antibiotic resistance.
“Our method doesn’t just save time – it uncovers pathogens other tests miss, enabling targeted treatments from the first critical hours.”
