Fighting antimicrobial resistant infections - A next-generation diagnostic device

GenomeKey正在开发下一代细菌血液感染诊断设备。我们的诊断将导致更早和更准确的细菌败血症检测和诊断，以及更快的抗菌药敏感性结果，从而带来更好的治疗、患者结局和可观的治疗成本节约。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的方法与其他当代细菌诊断方法的不同之处在于我们的创新技术。目前的黄金标准是，一种可以在几个小时内致死的疾病需要3天以上的时间。为了克服这一点，我们正在开发一种快速诊断方法，它直接从入侵病原体的基因组中对物种ID和抗菌素敏感性进行分类，并更快地获得所需的临床信息，将产生结果的时间从几天减少到只有六个小时。我们的技术直接从患者的血液中提取，不需要培养，是一种覆盖所有细菌种类的广泛检测方法。有了GenomeKey专有的机器学习方法，我们能够比现有的基于生物标志物靶板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败血症临床诊断和治疗向前迈出的重要一步。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的诊断是血培养的替代，将在几小时内检测出细菌病原体，而不是几天。该设备将被设计用于医院微生物学实验室，使用已经为疑似脓毒症而提取的标准血液，因此不需要改变现有的诊断管道。为了实现这笔赠款的目标，我们汇集了一支由专家科学家和工程师组成的团队，他们拥有强大的项目和商业管理经验。此外，我们的外部支持网络很广泛，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，我们将利用之前资助的研发成果，组装一个原型设备，以展示我们方法的临床疗效和影响，为扩大制造和临床试验做好准备。

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.