Inbiome Shatters Diagnostic Delays: IVDR-Certified Platform IDs Bacteria in 5 Hours Across EU Hospitals

www.inbiome.com

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

Amsterdam, the Netherlands – April 11, 2025 – 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.

/EIN News/ -- 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

About Inbiome
Founded in 2019, Inbiome is a Dutch molecular diagnostics pioneer on a mission to redefine infection management through its Molecular Culture ID platform, which combines untargeted PCR, AI-driven analysis, and cost-effective workflows. The company’s technology identifies over 200 bacterial pathogens—including antibiotic-treated or uncultivable species—within 5 hours, achieving high diagnostic accuracy in multisite trials. Optimized for critical samples like joint aspirates, cerebrospinal fluid, and surgical wound biopsies, the platform has earned IVDR certification and FDA Breakthrough Device Designation, accelerating its 2026 U.S. launch.

Inbiome’s partnerships with Amsterdam UMC, Maastricht University Medical Center, and leading E.U and U.S. hospitals validate its clinical impact: a 21% higher pathogen detection rate in joint infections and similar or even higher additional findings in other sample types. Beyond healthcare, the platform supports consumer brands in validating microbiome claims for products like probiotics and cosmetics.

Backed by the European Innovation Council and driven by a 2030 vision of same-day diagnostics for all infectious diseases, Inbiome is advancing a future where rapid, precise pathogen detection curbs antimicrobial resistance, slashes hospital stays, and empowers proactive healthcare.

For more information, visit inbiome’s website.

For further background info, please contact:

Inbiome, Amsterdam, the Netherlands
Dries Budding, CEO
Jord Budding, COO
Phone: +31 6 22 43 85 32  
Email: media.relations@inbiome.com

LifeSpring Life Sciences Communication, Amsterdam, the Netherlands
Leon Melens
Phone: +31 6 538 16 427
Email: lmelens@lifespring.bio