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Story 28 October 2024
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EIC Accelerator-backed Molecular Culture receives FDA Breakthrough Device Designation

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The EIC Accelerator beneficiary inbiome, a leading innovator 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 grant highlights the FDA’s recognition of the potential impact of inbiome’s technology in transforming the landscape of infectious disease diagnostics. The Molecular Culture focuses on creating the world’s first diagnostic test that can detect all bacterial species in a single assay. 

 

The FDA Breakthrough Device Designation 

The prestigious and highly competitive Breakthrough Device designation is awarded in exceptional cases, to devices that offer significant improvements over existing options. Indeed, the Breakthrough Devices Program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization. Breakthrough Devices must meet the FDA’s rigorous standards for device safety and effectiveness to be authorized for marketing. 

 

The Molecular Culture project 

Every year, bacterial infections cause 20% of human deaths. These deaths can be avoided only if the patients are administered correct medical treatment without any delays. Today, the diagnostic tests used to detect and identify bacteria are too slow or not comprehensive enough. Often, doctors have no other option but to administer antibiotic treatment based on educated guesswork which can lead to medical complications and increased patient care costs. To address these issues, inbiome is developing a cost-effective diagnostic test called “Molecular Culture” that detects and identifies over 200 bacterial species in clinical samples, providing same-day, highly accurate diagnoses. 

As part of the EIC project, inbiome is performing an implementation trial of Molecular Culture in a live hospital setting, optimizing the interface for hospital workflows, clinical validation of additional sample types, adding Anti-Microbial Resistance testing to the workflow, and expanding commercial skills. 

 

The team behind the innovation: a future-focused vision 

Inbiome plans to introduce its technology to the U.S. market by early 2026. To help make inbiome’s ambitious vision a reality, the company recently welcomed to its Advisory Board industry veteran Professor Carl Wittwer, who will bring invaluable expertise at a crucial time. Professor Wittwer, inventor of modern PCR technology (among others LightCycler®) and co-founder of Idaho Diagnostics (later: Biofire), will offer both technical guidance and business acumen. His experience will be instrumental in advancing inbiome’s mission to revolutionize bacterial diagnostics and expand its global impact. 

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,

said Professor Carl Wittwer. 

We are honored to receive this designation from the FDA said 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.

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 radically enhance global healthcare delivery and patient care.  

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.

added Jord Budding, COO of inbiome.

 

Additional information 

Inbiome’s groundbreaking work has been recognized and supported by the European Innovation Council (EIC). Within Horizon Europe, the company received a EIC Accelerator grant in 2023 to support the go-to-market strategy of its first in vitro diagnostic (IVD) device. This funding has been important in advancing the development and commercialization of Molecular Culture ID. 

Read more about the project on CORDIS

DISCLAIMER: This information is provided in the interest of knowledge sharing and should not be interpreted as the official view of the European Commission, or any other organisation.

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