The Sepsis ImmunoScore™ is the first-ever AI Sepsis Diagnostic granted marketing authorization by the FDA.

Sepsis ImmunoScore™是FDA首次授权上市的AI败血症诊断产品。

CHICAGO, April 3, 2024 /PRNewswire/ -- Prenosis, Inc., an artificial intelligence company enabling precision medicine in acute care, today announced the U.S. Food and Drug Administration (FDA) has granted marketing authorization for the Sepsis ImmunoScore™ using the De Novo pathway. The Sepsis ImmunoScore™ is an artificial intelligence/machine learning software as a medical device (AI SaMD) to guide rapid diagnosis and prediction of sepsis.

芝加哥，2024年4月3日/PRNewswire/--Prenosis，Inc.，一家在急性护理中实现精准医学的人工智能公司，今天宣布，美国食品和药物管理局（FDA）已使用从头途径授予Sepsis ImmunoScore™的上市许可。Sepsis ImmunoScore™是一种人工智能/机器学习软件，作为医疗设备（AI SaMD），用于指导败血症的快速诊断和预测。

This signifies the first-ever FDA marketing authorization of an AI diagnostic tool for sepsis, an extremely complex condition that is difficult to diagnose early and has been a decades-long challenge for the U.S. healthcare system..

这标志着美国食品和药物管理局首次批准用于脓毒症的人工智能诊断工具上市，脓毒症是一种极其复杂的疾病，很难早期诊断，对美国医疗保健系统来说是一项长达数十年的挑战。。

Sepsis, which occurs when a person has an overactive response to an infection, costs the U.S. healthcare system billions of dollars and kills millions of people every year – more than all cancers combined.1 Even if someone with sepsis survives an episode, the disease can have catastrophic and often permanent consequences on their quality of life after discharge.

脓毒症是一个人对感染反应过度活跃时发生的疾病，每年给美国医疗保健系统带来数十亿美元的损失，导致数百万人死亡，这比所有癌症的总和还要多。1即使脓毒症患者在一次发作中幸存下来，这种疾病也可能对他们出院后的生活质量产生灾难性的，往往是永久性的后果。

Despite the devastating impact, no AI diagnostic for sepsis had previously received marketing authorization from the FDA until now..

尽管产生了毁灭性的影响，但到目前为止，还没有针对败血症的AI诊断获得FDA的上市授权。。

Leveraging a combination of biomarkers and clinical data through AI, the Sepsis ImmunoScore™ aids in the risk assessment for presence of or progression to sepsis within 24 hours of patient assessment in the Emergency Department or hospital. By leveraging 22 diverse parameters, the Sepsis ImmunoScore™ holistically evaluates the patient's biological status to output a risk score and four discrete risk categories; it is not an alert system.

通过AI利用生物标志物和临床数据的组合，Sepsis ImmunoScore™有助于在急诊科或医院患者评估后24小时内对脓毒症的存在或进展进行风险评估。通过利用22个不同的参数，Sepsis ImmunoScore™全面评估患者的生物学状态，以输出风险评分和四个离散的风险类别；它不是一个警报系统。

These risk categories correlate to a patient's risk of deterioration, represented by length of stay in the hospital, in-hospital mortality, and escalation of care within 24 hours (ICU admission, mechanical ventilation placement, and/or vasopressor use). This combination of both diagnostic and predictive information had never previously been available in a legally marketed device for sepsis..

这些风险类别与患者的恶化风险相关，表现为住院时间，住院死亡率和24小时内护理升级（入住ICU，机械通气和/或使用血管加压药）。这种诊断和预测信息的结合以前从未在合法销售的败血症设备中提供过。。

'FDA authorization of a sepsis diagnostic tool with significant predictive power is a landmark event for people that could ever be at risk of sepsis at some point in their lives,' said Bobby Reddy, Jr, Ph.D., Prenosis Co-Founder and CEO. 'Until now, there was no other FDA authorized AI diagnostic for sepsis, which is why the Sepsis ImmunoScore™ had to be granted marketing authorization through the De Novo pathway.

Prenosis联合创始人兼首席执行官小鲍比·雷迪（BobbyReddy，Jr）博士说，美国食品和药物管理局（FDA）授权一种具有重要预测能力的败血症诊断工具，对于那些在生命中的某个时刻可能面临败血症风险的人来说，这是一个里程碑式的事件到目前为止，还没有其他FDA授权的脓毒症AI诊断，这就是为什么脓毒症ImmunoScore™必须通过从头途径获得上市授权的原因。

FDA authorization offers yet another important piece of evidence of the potential of the Sepsis ImmunoScore™ to improve care.'.

FDA的授权为脓毒症ImmunoScore™改善护理的潜力提供了另一个重要证据。”。

The Sepsis ImmunoScore's™ software is integrated directly into hospital Electronic Medical Records, making it easily accessible to clinicians. An intuitive display reveals how each of the individual patient's parameters was used to calculate their final sepsis score. This transparent look into the model is critical to build trust and intuition with clinicians and to enable a true clinician-AI partnership, which facilitates faster treatment decisions, improved outcomes, quality metrics, and better hospital financials..

脓毒症ImmunoScore™软件直接集成到医院电子病历中，使临床医生易于访问。直观的显示揭示了如何使用每个患者的参数来计算他们的最终败血症评分。这种对模型的透明研究对于与临床医生建立信任和直觉至关重要，并且能够建立真正的临床医生AI合作伙伴关系，从而促进更快的治疗决策，改善结果，质量指标和更好的医院财务状况。。

A solution such as the Sepsis ImmunoScore™ has significant potential to save lives, reduce hospital length of stay, and improve compliance with payer protocols – such as the Center for Medicare and Medicaid Services' SEP-1 bundle. The SEP-1 bundle is expected to have significant financial implications for hospitals across the United States by as early as 2026..

脓毒症免疫核心（Sepsis ImmunoScore™等解决方案在挽救生命、缩短住院时间和提高对付款人协议（如医疗保险和医疗补助服务中心的SEP-1捆绑包）的遵守方面具有巨大潜力。预计到2026年，SEP-1捆绑包将对美国各地的医院产生重大的财务影响。。

The Sepsis ImmunoScore™ was built using Prenosis' Immunix™ precision medicine platform, a solution enabling precision medicine in acute care. Immunix™ simultaneously empowers the development and validation of new precision medicine tools and the real-time implementation of those tools to improve patient care and outcomes.

脓毒症免疫核心™是使用Prenosis的Immunix™精准医学平台构建的，该平台是一种在急性护理中实现精准医学的解决方案。Immunix™同时支持开发和验证新的精准医学工具，并实时实施这些工具，以改善患者护理和结果。

Through a decade of collaboration with ten partner hospitals across the United States, Prenosis used ImmunixTM to build a proprietary biobank and dataset consisting of more than 100,000 blood samples from over 25,000 patients housed in Prenosis' Biological Safety Level 2 lab in Chicago. Prenosis uses in-house assays in its wet lab to generate critical biological data from these blood samples and merges these data with extensive clinical data extracted from partner hospitals' Electronic Medical Records.

通过与美国十家合作医院的十年合作，Prenosis使用ImmunixTM建立了专有的生物库和数据集，其中包含来自芝加哥Prenosis生物安全2级实验室25000多名患者的100000多份血液样本。Prenosis在其湿实验室中使用内部分析来从这些血液样本中生成关键的生物学数据，并将这些数据与从合作医院的电子病历中提取的大量临床数据合并。

This dual biological-clinical dataset, the largest in the world for acute care patients suspected of having serious infections, is used to develop AI algorithms to elucidate patterns in rapid immune response. The ultimate goal is to enable a deep understanding of each person's individual biology, then use this understanding to recommend personalized therapeutics in real time in the acute care environment. .

这个双重生物学临床数据集是世界上最大的疑似患有严重感染的急性护理患者的数据集，用于开发AI算法以阐明快速免疫反应的模式。最终目标是深入了解每个人的个体生物学，然后利用这种理解在急性护理环境中实时推荐个性化治疗方法。。

'The Sepsis ImmunoScore™ FDA authorization marks an important step in helping hospital systems provide better care,' said Reddy. 'Similar to how sequencing technology enabled the precision medicine revolution in cancer, our powerful Immunix™ platform has the potential to unlock valuable insights to enable the creation of precision therapeutics guided by AI diagnostics.

雷迪说：“脓毒症免疫核心™FDA授权标志着帮助医院系统提供更好护理的重要一步。”与测序技术如何推动癌症精准医学革命类似，我们强大的Immunix™平台有可能释放有价值的见解，从而能够创建由AI诊断指导的精准治疗方法。

To date, this type of approach has been used predominantly in healthcare outside of emergency departments and hospitals. Prenosis seeks to change this by catalyzing a personalized medicine revolution in acute care.'.

迄今为止，这种方法主要用于急诊科和医院以外的医疗保健。Prenosis试图通过催化急性护理中的个性化医学革命来改变这一现状。”。

The Sepsis Immunoscore™ is a registered trademark of Prenosis Inc.

Sepsis Immunoscore™是Prenosis Inc.的注册商标。

About Prenosis

关于Prenosis

At Prenosis we believe healthcare should be tailored to individual biology. With our data-driven approach to fast-moving biology in acute care environments, we're ushering in a new era of precision medicine in acute care. Our Immunix™ precision medicine platform generates proprietary biological insights to rapidly develop precision medicine products and enables the real-time delivery of optimal precision therapy in acute care.

在Prenosis，我们认为医疗保健应该针对个体生物学进行调整。通过我们在急性护理环境中快速发展生物学的数据驱动方法，我们正在开创急性护理精准医学的新时代。我们的Immunix™精准医学平台产生专有的生物学见解，以快速开发精准医学产品，并能够在急性护理中实时提供最佳的精准治疗。

The platform is based on the world's largest and fastest growing biomarker-clinical dataset for rapid immune response. Using Immunix™, we created and validated the Sepsis ImmunoScore™, the first FDA-authorized AI diagnostic for sepsis..

该平台基于世界上最大且增长最快的生物标志物临床数据集，用于快速免疫反应。使用Immunix™，我们创建并验证了败血症ImmunoScore™，这是FDA批准的第一个败血症AI诊断。。

At Prenosis, we enable the healthcare ecosystem to see people differently. More information at: www.prenosis.com

在Prenosis，我们使医疗保健生态系统以不同的方式看待人们。更多信息请访问：www.prenosis.com

1 Rudd, K. E. et al. Global, regional, and national sepsis incidence and mortality, 1990–2017: analysis for the Global Burden of Disease Study. The Lancet 395, 200–211 (2020).

1 Rudd，K.E.等人，《1990-2017年全球，区域和国家败血症发病率和死亡率：全球疾病负担研究分析》。柳叶刀395200-211（2020）。

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