Inbiome Shatters Diagnostic Delays: IVDR-Certified Platform IDs Bacteria in 5 Hours Across EU Hospitals
- Hours, Not Days: EU Approval Accelerates 5-Hour Pathogen ID for Critical Cases
- Molecular Fingerprinting: AI-Powered ‘DNA Barcode’ Spots 200+ Species, Including Uncultivable Pathogens
- Hospital Laboratories Across Europe Now Have Immediate Access To a Fully Certified, Untargeted Molecular Diagnostics Platform
Inbiome, a pioneering Dutch diagnostics company, announced today that it has received IVDR (In Vitro Diagnostic Regulation) certification from the European Union for its revolutionary rapid bacterial identification system. This milestone authorizes immediate commercial deployment across the EU for rapid bacterial identification in critical clinical samples—including synovial fluid, cerebrospinal fluid, and tissue biopsies. By reducing diagnostic delays from days to hours, the advancement is poised to transform how healthcare providers diagnose and treat infections.
The technology uses a unique “DNA barcode” approach to identify bacterial pathogens within hours—a dramatic improvement over traditional culture-based methods that require days. By analyzing the length of a conserved genetic region present in all bacteria, the test achieves high specificity even for elusive pathogens. Ongoing clinical trials at Amsterdam UMC’s Emma Children’s Hospital are showing its potential to reduce unnecessary antibiotic use in newborns with fever, while an Austrian study reported a 30% additional detection rate in joint infections with unexpected negative culture outcomes.
“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,” said dr. Dries Budding, CEO of Inbiome. “Our method doesn’t just save time—it uncovers pathogens other tests miss, enabling targeted treatments from the first critical hours.”
Building on its recent FDA Breakthrough Device Designation, Inbiome’s IVDR certification cements its position as a transatlantic leader in rapid infection diagnostics. This combination of regulatory milestones accelerates the company’s planned 2026 U.S. market entry while enabling immediate European deployment in critical care settings.
“This milestone unlocks our European expansion, driving toward our 2030 vision of same-day diagnostics for all infections,” said COO Jord Budding.
Inbiome plans to leverage its EU certification to expand partnerships with hospitals and laboratories, supported by a forthcoming funding round to accelerate commercial and R&D efforts. The company is collaborating with Amsterdam UMC and over 15 other hospitals in Europe and the US for real-world validation studies, optimizing workflows to slash time-to-treatment gaps.
Molecular Culture ID platform
Inbiome’s Molecular Culture ID platform redefines bacterial diagnostics by delivering actionable results up to 20x faster than traditional culture methods, overcoming longstanding delays that compromise patient care. Unlike slow, labor-intensive legacy approaches, the platform combines untargeted PCR and AI to identify over 200 bacterial
species—including uncultivable or antibiotic-treated pathogens—with high diagnostic accuracy. It can even detect unknown pathogens at the phylum level, a critical advantage in complex infections. By providing results within 5 hours (vs. days for culture), without a costly sequencing workflow, the technology can enable clinicians to initiate precise treatments earlier, potentially reducing unnecessary antibiotic use and slashing hospital stays.
Differentiators Against Legacy Methods
| Feature | Molecular Culture ID | Traditional Culture |
| Time to Result | <5 hours | 2-5 days |
| Detection Scope | 200+ species in database. Reports most other species to the phylum level. | Limited to cultivable pathogens |
| Antibiotic-Treated | Detects | Often misses |
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