Combatting Antimicrobial Resistance with Next-Generation Diagnostics for Sepsis

GenomeKey正在开发下一代即时诊断设备，用于败血症患者的细菌血液感染。我们的诊断将导致更早，更准确地检测和诊断细菌性败血症，更快地获得抗菌药物敏感性结果，从而获得更好的治疗，患者结局和可观的治疗成本节省。此外，我们的设备将使临床医生能够更好地管理抗生素的使用，并在医院和社区提供对抗菌素耐药性和病原体菌株的广泛监测，从而实现更好的抗生素管理并限制耐药性的传播。GenomeKey的方法与其他当代感染诊断方法的区别在于我们的创新技术。目前的黄金标准需要3天以上的条件，可以在几个小时内杀死。为了克服这一点，我们开发了一种快速诊断方法，该方法直接从入侵病原体的基因组中对物种ID和抗菌药物敏感性进行分类，并更快地获得所需的临床信息，将得出结果的时间从几天缩短到几小时。通过GenomeKey专有的机器学习方法，我们能够比现有的基于目标生物标志物的测试更准确地确定抗生素耐药性。GenomeKey正在开发的医疗诊断设备将是脓毒症临床诊断和治疗的重要一步。快速基因组测序使我们能够绕过培养的需要，这是当今实践中的基本限制步骤。GenomeKey的诊断是血液培养的替代品，将在几小时内检测到传染性病原体，而不是几天。该设备将被设计用于医院微生物实验室和床旁，使临床医生能够在患者床边从样本到结果。为了实现这一赠款的目标，我们汇集了一批专家科学家和工程师，由强大的项目和业务管理和商业经验的支持。此外，我们的外部支持网络是广泛的，包括NHS临床医生和微生物学家，以及学术健康科学网络（AHSN）。通过这笔赠款，我们将保护我们的关键知识产权，制定我们的监管途径，开发概念验证原型设备，并通过体内模型进行验证，为下一阶段的产品开发和临床测试做好准备。

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.