Inbiome, a molecular diagnostics company based in the Netherlands, has secured certification under the European Union’s (EU) In Vitro Diagnostic Regulation (IVDR) for its rapid bacterial identification platform, Molecular Culture ID.
This authorisation enables immediate deployment across EU hospitals, allowing for the identification of bacteria in critical clinical samples such as synovial fluid, cerebrospinal fluid, and tissue biopsies within five hours.
The development marks a significant reduction in diagnostic times from days to hours, facilitating improved infection diagnosis and treatment, claimed Inbiome.
The company’s technology utilises a DNA barcode approach to identify bacterial pathogens swiftly, outperforming traditional culture-based methods that typically require several days. By examining a conserved genetic region found in all bacteria, the test maintains high specificity, even for challenging pathogens.
Clinical trials at Amsterdam UMC’s Emma Children’s Hospital highlight the system’s potential to decrease unnecessary antibiotic use in febrile newborns. An Austrian study has also demonstrated a 30% increase in detection rates for joint infections where cultures previously returned negative.
Inbiome’s receipt of the IVDR certification follows its US Food and Drug Administration (FDA) breakthrough device designation.
To enhance its market presence, Inbiome intends to form additional partnerships with hospitals and laboratories across Europe. This effort will be supported by an upcoming funding round aimed at accelerating commercialisation and research initiatives.
The company is collaborating with Amsterdam UMC and over 15 other hospitals in Europe and the US to undertake real-world validation studies, focusing on improving workflow efficiency and reducing treatment delays.
Inbiome’s Molecular Culture ID platform is claimed to provide results up to 20 times faster than traditional methods. The system employs untargeted PCR combined with artificial intelligence (AI) technology to accurately identify over 200 bacterial species, including those that cannot be cultured or have been previously treated with antibiotics.
It can also detect unknown pathogens at the phylum level, offering vital insights into complex infections, said the company.
Inbiome further said that with results available within five hours without the need for expensive sequencing workflows, clinicians are equipped to administer targeted treatments more swiftly. This potentially cuts down on unnecessary antibiotic use and shortening hospital stays.
