Public Funding for Genomic Labs Ltd

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.

GenomeKey is developing a next-generation point-of-care diagnostic device for bacterial blood infections in cases of sepsis. 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 strain 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 infection 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 have developed 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 hours. 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 infectious agent within hours, rather than days. This device will be designed for use within hospital microbiology labs and for Point-Of-Care, allowing clinicians to go from sample to result at the patient bedside. 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 protect our key intellectual property, set out our regulatory pathway, develop a proof-of-concept prototype device and validate this with _in vivo_ models, preparing us for the next phase of product development and clinical testing.

GenomeKey determines how to treat Sepsis in hours, rather than days. This is important because Sepsis now kills more people than cancer, and can kill within hours. For a patient admitted to a hospital today, they would wait 3 days before the doctor knows which antibiotic will fight the infection. GenomeKey reduces this time using cutting edge machine learning and DNA sequencing to bring those 3 days down to just a few hours. This saves lives, saves money, and saves our last antibiotics for when we really need them. This is particularly important in the case of COVID-19 bacterial co-infection. Not only is our target antibiotic susceptibility test cost substantially lower than other approaches, but we also reduce the time taken to determine a negative bacterial sample from 5 days to only hours, enabling the clinician to confidently avoid antibiotics when no bacteria is present. This substantially prevents unnecessary antibiotic usage. This programme addresses the challenge of bacterial co-infection with COVID-19, and the increasing debt of antimicrobial resistance. The overall proportion of COVID-19 patients with respiratory bacterial infection is 7.1% (8.1% for critically ill patients). The majority of patients with COVID-19 received antibiotics (71.3%) even though antibiotics are not effective against viral infections. The use of antibiotics is often prophylactic, which is necessary due to the diagnostic uncertainty with a patient presenting respiratory infection symptoms. However, the rise of antimicrobial resistance among bacterial populations before COVID was a global crisis. Now, with widespread antibiotic overuse during COVID-19, we have increased our AMR debt even further. This presents a looming healthcare crisis once the focus on COVID has subsided where our antibiotics will be increasingly ineffective.