Summary: Inbiome’s Molecular Culture ID for rapid bacterial infection diagnostics received FDA Breakthrough Device Designation.
Takeaways:
- Molecular Culture ID combines advanced chemistry and AI to provide same-day identification of over 200 bacterial species, improving patient outcomes and reducing healthcare costs.
- Bacterial infections cause one in five deaths worldwide, and current diagnostic methods can take days, delaying treatment and prolonging hospital stays.
- Inbiome aims to launch its technology in the U.S. by 2026, with a vision to achieve same-day diagnostics for all infectious diseases by 2030, contributing to the global fight against antimicrobial resistance.
Diagnostic technologies provider inbiome announced that its Molecular Culture ID for bacterial infection diagnostics has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA).
This grant highlights the FDA’s recognition of the potential impact of inbiome’s technology in transforming the landscape of infectious disease diagnostics, the company says.
Impact of Bacterial Infections
Bacterial infections significantly impact public health, causing one in five human deaths worldwide. Current diagnostic methods often require several days to yield results. With hospitals typically performing hundreds of bacterial diagnostic tests every day, this delay is problematic, as it delays correct treatment, prolongs hospital stays and negatively impacts patient outcomes.
What is Molecular Culture ID?
Molecular Culture ID is a new diagnostic test that addresses these challenges by combining advanced chemistry with AI, to rapidly detect and identify over 200 bacterial species from various bodily samples. This technology provides same-day, highly accurate diagnoses, significantly reducing waiting times, improving patient outcomes, and lowering healthcare costs.
By enhancing the diagnosis of critical infections, including pleural, peritoneal, joint, bone, pericardial, and surgical wound infections, Molecular Culture ID aims to represent a major advancement in the timely and effective treatment of bacterial infections, the company says.
Inbiome plans to introduce its technology to the U.S. market by early 2026 and is currently partnering with leading U.S. hospitals on implementation studies. This will facilitate seamless integration into U.S. hospital workflows.
“We are honored to receive this designation from the FDA,” says Dries Budding, CEO of inbiome. “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.”
A Focus on the Future
The Molecular Culture ID is the first in a series of new diagnostic technologies that inbiome plans to introduce over the coming years. The company’s vision is to achieve same-day diagnostics for all infectious diseases by 2030, which promises to enhance global healthcare delivery and patient care radically.
“Our vision of achieving same-day diagnostics for all infectious diseases by 2030 is ambitious but within reach,” added Jord Budding, COO of inbiome. “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.”
Photo: inBiome
