A prototype diagnostic device can identify bacterial blood infections and their antibiotic resistance profile in six hours, rather than the current three-day standard. This matters because sepsis can kill within hours, yet today’s gold-standard test requires growing bacteria from a blood sample—a slow process that delays targeted treatment. GenomeKey’s device skips culturing entirely, reading the pathogen’s genome directly from the patient’s blood. A proprietary machine-learning algorithm then classifies both the bacterial species and its antimicrobial susceptibility with greater accuracy than existing biomarker-based tests. If successful, the device could transform sepsis management in hospital microbiology labs. Clinicians would receive actionable results within a single shift, enabling earlier, more precise antibiotic use. This would improve patient survival, reduce treatment costs, and support antibiotic stewardship by curbing unnecessary broad-spectrum prescriptions. The same genomic data could also feed into hospital and community surveillance systems, tracking resistance patterns and pathogen strains in real time. The current grant funds assembly of a prototype to demonstrate clinical efficacy, paving the way for scaled manufacturing and clinical trials.
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GenomeKey is developing a next-generation diagnostic device for bacterial blood infections. Our diagnostic will result in earlier and more accurate detection and diagnosis of bacterial sepsis, and faster antimicrobial susceptibility results, leading to better treatment, patient outcomes and considerable treatment cost savings. In addition, our device will allow clinicians to better manage use of antibiotics and provide broad surveillance of antimicrobial resistance and pathogen strains in hospitals and communities, thereby enabling better antibiotic stewardship and limiting the spread of resistance. What sets GenomeKey's approach apart from other contemporary approaches to bacterial diagnosis is our innovative technology. The current gold standard takes upwards of 3 days for a condition that can kill in hours. To overcome this we are developing a rapid diagnostic which classifies species ID and antimicrobial susceptibility directly from the genome of the invading pathogen and arrives at the desired clinical information much faster, reducing the time to result from days to only six hours. Our technology works directly from patient blood, with no culturing required, and is a broad assay covering all species of bacteria. With GenomeKey's proprietary machine learning approach we are able to determine the antibiotic resistance to a greater accuracy than existing tests which are based on a target panel of biomarkers. The medical diagnostic device GenomeKey is developing will be a significant step forward for the clinical diagnosis and treatment of sepsis. Rapid genomic sequencing enables us to bypass the need for culturing which is the fundamental limiting step in today's practice. GenomeKey's diagnostic is a replacement for blood culture and will detect the bacterial pathogens within hours, rather than days. This device will be designed for use within hospital microbiology labs, using the standard blood draw already taken for suspected sepsis, thus requiring no change to the existing diagnostic pipeline. To achieve the objectives of this grant we have brought together a team of expert scientists and engineers, supported by strong project and business management and commercial experience. Moreover, our external support network is expansive, including NHS clinicians and microbiologists, and the Academic Health Science Networks (AHSN). Through this grant, we will take the outputs of previously funded R&D and assemble a prototype device to demonstrate the clinical efficacy and impact of our approach, preparing us for scaled up manufacturing and clinical trials.
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