Inbiome’s rapid diagnostic platform approved for EU use, cuts infection identification time to just five hours
Ella Day | April 11, 2025 | News story | Research and Development | Diagnostics, EU, Inbiome
Dutch diagnostics firm Inbiome has received In Vitro Diagnostic Regulation (IVDR) certification from the EU for its Molecular Culture ID platform, allowing hospitals across Europe to rapidly identify bacterial infections within five hours. This is significantly faster than conventional culture-based methods that can take days.
The platform uses a unique DNA barcode approach to identify over 200 bacterial species, including hard-to-detect, antibiotic-treated or uncultivable pathogens. Powered by untargeted polymerase chain reaction (PCR) and artificial intelligence (AI), the test analyses a conserved genetic region found in all bacteria, offering specific results without the need for costly sequencing.
The certification marks a major milestone in infection diagnostics. Early trials at Amsterdam UMC’s Emma Children’s Hospital suggest the system could reduce unnecessary antibiotic use in newborns with fever, while a separate Austrian study reported a 30% increase in detection rates for joint infections that returned negative cultures.
“This is a turning point in infection diagnostics,” said Inbiome chief executive officer Dries Budding. “By delivering results in hours instead of days, we’re equipping clinicians with the tools to treat infections faster and more precisely.”
The platform’s speed and accuracy are especially impactful for critical sample types such as cerebrospinal fluid, synovial fluid and wound biopsies. It also supports the detection of unknown pathogens at the phylum level – critical in complex cases.
Following its recent US Food and Drug Administration Breakthrough Device Designation, the IVDR certification positions Inbiome as a global leader in infection diagnostics, with a US market launch planned for 2026. The company is now expanding hospital partnerships and preparing for a funding round to accelerate commercial and R&D growth.
Ella Day
11/4/25
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