Prenosis, Roche Partner to Combat Hospital Sepsis Using Precision Diagnostics

罗氏合作伙伴,使用精确诊断技术对抗医院脓毒症

2021-10-15 04:30:06 HIT Consultant

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What You Should Know:  – Prenosis Inc., a precision diagnostics company transforming clinical diagnosis with artificial intelligence, announced today the expansion of an existing partnership with Roche Diagnostics that will total close to $6 million to improve and expedite the clinical recognition of sepsis. – Building upon the collaboration that the companies started together in 2020, Prenosis will significantly expand its core NOSIS™ dataset, and the two companies will work together to obtain U.S. Food and Drug Administration (FDA) clearance for the Prenosis Sepsis Immunoscore™ and the Roche Elecsys® IL-6 Assay.  These tools aim to provide physicians with powerful new solutions for fighting sepsis through early risk identification. Impact of Sepsis According to the World Health Organization, more than 11 million people die from sepsis worldwide annually, more than the deaths caused by all cancers combined.  Studies show that sepsis is the leading cause of death in U.S. hospitals, with total annual costs of treatment and rehabilitation estimated at $62 billion. Before the COVID-19 pandemic, at least 1.7 million adults in the United States developed sepsis annually.  During the pandemic, this problem was greatly exacerbated, as most COVID-19 deaths are due to viral and/or bacterial sepsis. Early prediction of at-risk patients that require emergency department evaluation and hospitalization can dramatically improve outcomes. Combining routinely obtained clinical information with additional critical biomarkers could help identify at-risk patients earlier and more accurately for life-saving treatment. Prenosis Dataset The Prenosis dataset, which features Elecsys IL-6 measurements, in addition to measurements of a diverse set of parameters representing several different dimensions of immune response, is the world’s largest and fastest growing hybrid biomarker-clinical dataset for sepsis care.  The partnership drives the unique combination of a traditional diagnostic test with next-generation predictive analytics, demonstrating the potential to usher in a new era of holistic digital diagnostics for more comprehensive profiling of complex heterogeneous hospital conditions. The Roche Elecsys® IL-6 assay measures interleukin-6 concentrations from patient plasma or serum samples. Elecsys IL-6 is a predictive biomarker essential in the disease pathways of many inflammatory conditions, including sepsis thanks to its early elevation. The Elecsys IL6 results can be provided in 18 minutes. The Prenosis Sepsis Immunoscore™ diagnostic utilizes the combination of Elecsys IL-6 with other sepsis biomarkers and distinct clinical risk parameters and aims to predict, diagnose and treat sepsis earlier. The Sepsis ImmunoScore™ is an Artificial Intelligence/Machine Learning (AI/ML) Software as a Medical Device (SaMD) that Prenosis intends to submit to the FDA for clearance by the end of the year. It is intended to aid in the risk assessment for progression to sepsis of patients admitted to the emergency department or hospital. The solution incorporates holistic, multidimensional inputs using machine learning to more adequately capture the vast heterogeneity of sepsis and to improve the accuracy of diagnosis compared to the current standard of care risk assessments. The solution incorporates 23 parameters from the patient’s hospital Electronic Medical Record (EMR), including demographics, vital signs, labs, and other specific sepsis biomarkers, including Elecsys IL-6. The diagnostic creates a calculated sepsis risk score, a risk stratification category and other supplemental information that can be visualized in a unique Sepsis Patient View within a hospital Electronic Medical Record or via a web interface. By employing parameters representing many dimensions of information, the Sepsis ImmunoScore™ seeks to more effectively diagnose sepsis and risk stratify patients for care based on severity of illness.
你应该知道的是: -Prenosise Inc.是一家用人工智能改造临床诊断的精密诊断公司,该公司今天宣布扩大与罗氏诊断公司的现有合作伙伴关系,总额将接近600万美元,以改善和加快脓毒症的临床识别。 -在两家公司于2020年开始合作的基础上,Prenosis将大幅扩展其核心Nosis™数据集,两家公司将共同努力获得美国食品药品监督管理局(FDA)对Prenosis败血症免疫科™和罗氏Elecsys®IL-6检测的许可。这些工具旨在通过早期风险识别为医生提供强大的新解决方案来对抗脓毒症。 脓毒症的影响 根据世界卫生组织的数据,全球每年有1100多万人死于败血症,比所有癌症造成的死亡总和还要多。研究表明,败血症是美国医院的主要死亡原因,每年治疗和康复总费用估计为620亿美元。在新冠肺炎疫情之前,美国每年至少有170万成年人患上败血症。在疫情期间,这个问题大大加剧,因为大多数新冠肺炎死亡是由于病毒和/或细菌败血症。 早期预测需要急诊评估和住院的高危患者可以显著改善结果。将常规获得的临床信息与额外的关键生物标志物相结合,可以帮助更早更准确地识别高危患者,以挽救生命。 婚前数据集 Prenosis数据集是世界上最大和增长最快的用于脓毒症护理的混合生物标志物-临床数据集,除了Elecsys IL-6测量之外,还包括代表免疫反应几个不同维度的各种参数的测量。该伙伴关系推动了传统诊断测试与下一代预测分析的独特结合,展示了开创整体数字诊断新时代的潜力,以更全面地分析复杂的异构医院状况。 罗氏Elecsys®IL-6测定法测量患者血浆或血清样本中的白细胞介素-6浓度。Elecsys IL-6是一种预测性生物标志物,在许多炎症条件的疾病通路中至关重要,包括脓毒症,这要归功于它的早期升高。Elecsys IL6的结果可以在18分钟内提供。Elecsys IL-6与其他败血症生物标志物和独特的临床风险参数相结合,旨在早期预测、诊断和治疗败血症。 败血症免疫科™是一种人工智能/机器学习(AI/ML)软件,作为一种医疗设备(SaMD),普伦西斯打算在年底前提交给FDA批准。它的目的是帮助评估进入急诊科或医院的病人进展为败血症的风险。该解决方案结合了整体的、多维的输入,使用机器学习来更充分地捕捉脓毒症的巨大异质性,并与当前的护理风险评估标准相比,提高诊断的准确性。该解决方案包含23个来自患者医院电子病历(EMR)的参数,包括人口统计、生命体征、实验室和其他特定的败血症生物标志物,包括Elecsys IL-6。 该诊断创建了计算的脓毒症风险评分、风险分层类别和其他补充信息,这些信息可以在医院电子病历内的唯一脓毒症患者视图中或通过web界面可视化。通过使用代表许多信息维度的参数,脓毒症免疫系统™寻求更有效地诊断脓毒症,并根据疾病的严重程度对患者进行风险分层。

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