Inbiome, a leader in diagnostic technologies, announced that its Molecular Culture ID has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). This designation underscores the FDA's recognition of the technology's potential to significantly improve infectious disease diagnostics.
Addressing Delays in Bacterial Infection Diagnosis
Bacterial infections pose a substantial global health challenge, contributing to one in five deaths worldwide. Conventional diagnostic methods often require several days to produce results, leading to delays in appropriate treatment, prolonged hospital stays, and adverse patient outcomes. Hospitals typically conduct hundreds of bacterial diagnostic tests daily, highlighting the critical need for faster and more accurate diagnostic tools.
Molecular Culture ID: A Novel Diagnostic Approach
Molecular Culture ID addresses these challenges by integrating advanced chemistry with artificial intelligence (AI) to rapidly detect and identify over 200 bacterial species from various bodily samples. This innovative technology delivers highly accurate diagnoses within the same day, significantly reducing waiting times, enhancing patient outcomes, and potentially lowering healthcare costs. The test is designed to improve the diagnosis of critical infections, including those affecting the pleura, peritoneum, joints, bones, pericardium, and surgical wounds.
U.S. Market Introduction and Implementation
Inbiome anticipates launching Molecular Culture ID in the U.S. market by early 2026 and is currently collaborating with leading U.S. hospitals on implementation studies to ensure seamless integration into existing hospital workflows.
Expert Commentary
Professor Carl Wittwer, a member of inbiome’s Advisory Board and inventor of modern PCR technology, stated, "inbiome’s PCR technology provides a unique analysis, capable of distinguishing hundreds of bacterial pathogens in a single multiplex test. The U.S. FDA's Breakthrough Device Designation will speed this innovative technology into the U.S. market. I look forward to more interaction with the ground-breaking team at inbiome."
Dries Budding, CEO of inbiome, added, "We are honored to receive this designation from the FDA. With Molecular Culture ID our ambition is to revolutionize diagnostics of infectious diseases. This recognition by the FDA will help us bring this innovation to patient care as soon as possible."
Future Vision and Antimicrobial Resistance
Molecular Culture ID is the first in a series of diagnostic technologies that inbiome plans to introduce. The company aims to achieve same-day diagnostics for all infectious diseases by 2030. Jord Budding, COO of inbiome, noted, "Our vision of achieving same-day diagnostics for all infectious diseases by 2030 is ambitious but within reach. This milestone will not only enhance patient outcomes but also play a crucial role in the fight against the global threat of antimicrobial resistance, by ensuring antibiotics are used appropriately and effectively."
Support from the European Innovation Council
Inbiome's work is supported by the European Innovation Council (EIC), which awarded the company an EIC Accelerator grant in 2023 to facilitate the commercialization of its first in vitro diagnostic (IVD) device.
