Large scale study confirms Cytovale's IntelliSep test accurately predicts sepsis risk and severity, aids in appropriate triage and treatment pathways in emergency departments

大规模研究证实，Cytovale的IntelliSep测试可以准确预测败血症的风险和严重程度，有助于急诊科进行适当的分类和治疗途径

SAN FRANCISCO, May 2, 2024 /PRNewswire/ -- Cytovale®, a commercial-stage medical diagnostics company focused on advancing early detection technologies to diagnose fast-moving and immune-mediated diseases, today announced the publication of a new peer reviewed-study in 'Academic Emergency Medicine'' that demonstrates strong diagnostic performance of the company's IntelliSep® host response test for sepsis detection.

旧金山，2024年5月2日/PRNewswire/--Cytovale®是一家商业阶段的医疗诊断公司，专注于推进早期检测技术以诊断快速移动和免疫介导的疾病，今天宣布在“学术急诊医学”中发表一项新的同行评审研究，该研究证明了该公司IntelliSep®宿主反应测试对败血症检测的强大诊断性能。

The study analyzed 1,002 patients and evaluated the accuracy of IntelliSep to rapidly diagnose patients with sepsis and help clinicians expedite appropriate care..

该研究分析了1002名患者，并评估了IntelliSep快速诊断败血症患者并帮助临床医生加速适当护理的准确性。。

'The impressive diagnostic and prognostic performance of IntelliSep seen in this study is comparable to results seen for critical tests used for other emergent conditions seen in the Emergency Department (ED), such as heart attack and pulmonary embolism,' said Dr. Hollis O'Neal, a Pulmonary and Critical Care Physician for LSU New Orleans and Medical Director of Research for Our Lady of the Lake Health.

路易斯安那州立大学新奥尔良分校（LSU NewOrleans）肺科和重症监护医生、《我们的湖之夫人健康》（The Lady of The Lake Health）医学研究主任霍利斯·奥尼尔（Hollis O'Neal）博士说：“IntelliSep在这项研究中令人印象深刻的诊断和预后表现，与急诊科（ED）用于其他紧急情况（如心脏病发作和肺栓塞）的关键测试结果相当。”。

'This study shows enormous promise for the first-ever objective measure of immune activation. With a tool like IntelliSep, ED providers can be armed with the knowledge they need to guide potentially septic patients to the appropriate care pathway.'.

“这项研究为首次客观测量免疫激活显示出巨大的希望。通过IntelliSep等工具，ED提供者可以获得所需的知识，以指导潜在的脓毒症患者进入适当的护理途径。”。

The IntelliSep test is the only test of its kind that is U.S. Food and Drug Administration (FDA)-cleared for detecting sepsis in an adult population that presents with signs and symptoms of infection to the Emergency Department. The test provides critical new information about immune activation and sepsis risk stratification through a simple blood draw in about 8 minutes..

IntelliSep测试是美国食品和药物管理局（FDA）批准的唯一一种测试，用于检测成年人群中出现感染迹象和症状的败血症。该测试通过大约8分钟的简单抽血，提供了有关免疫激活和败血症风险分层的关键新信息。。

This study is a pooled analysis of 1,002 patients composed of five distinct, but similar, adult cohorts who presented in seven geographically diverse EDs across the U.S. with signs or suspicion of infection. IntelliSep was evaluated for accurately diagnosing sepsis and providing a rapid, objective tool for determining the risk and severity of sepsis in these patients.

这项研究是对1002名患者的汇总分析，这些患者由五个不同但相似的成年队列组成，他们在美国七个地理位置不同的急诊室出现感染迹象或怀疑感染。IntelliSep被评估为准确诊断败血症，并为确定这些患者败血症的风险和严重程度提供了一种快速，客观的工具。

Among the findings, key highlights include:.

在调查结果中，主要亮点包括：。

IntelliSep demonstrated impressive 'rule-out' performance related to sepsis, with a Negative Predictive Value of 97.5%, which, combined with the 0.0% sepsis mortality rate for patients with low risk scores, may allow the care team to explore alternative diagnoses in low risk patients.

IntelliSep表现出与败血症相关的令人印象深刻的“排除”表现，阴性预测值为97.5%，加上低风险评分患者的败血症死亡率为0.0%，可能使护理团队能够探索低风险患者的替代诊断。

The test showed similar 'rule-in' performance to other critical ED tests, with a Positive Predictive Value of 55%.

该测试显示出与其他关键ED测试类似的“规则”性能，阳性预测值为55%。

More than 50% of the patients observed were classified by the IntelliSep test as having a low risk of sepsis, yet, the number of these patients treated with antibiotics was comparable to the number of patients treated with antibiotics that received a high risk score.

超过50%的患者被IntelliSep测试归类为败血症风险低，然而，这些接受抗生素治疗的患者数量与接受高风险评分的抗生素治疗的患者数量相当。

'These findings spotlight how IntelliSep enables clinicians to detect sepsis earlier in patients for whom the condition wasn't otherwise suspected. Conversely, IntelliSep also provides an objective tool for clinicians to rule out sepsis and move onto an alternative diagnosis,' said Dr. O'Neal.

“这些发现突显了IntelliSep如何使临床医生能够在没有其他怀疑的患者中尽早发现败血症。相反，IntelliSep也为临床医生提供了一个客观的工具，可以排除败血症并进行替代诊断，”奥尼尔博士说。

'This study provides the most comprehensive picture of IntelliSep data available to date. It highlights the potential impact of the IntelliSep test on clinical outcomes and the potential savings that hospitals may achieve through more efficient and effective sepsis care,' said Cytovale CEO Ajay Shah..

“这项研究提供了迄今为止可用的IntelliSep数据的最全面的图片。Cytovale首席执行官Ajay Shah说，这突出了IntelliSep测试对临床结果的潜在影响，以及医院通过更高效和有效的败血症护理可能实现的潜在节约。。

Cytovale is currently working with selected early access partners to integrate the IntelliSep test into their ED screening processes. Recent data from Our Lady of the Lake Regional Medical Center, a large academic medical center in Baton Rouge, La. and early adopter of the test, found that when IntelliSep was integrated early in an ED sepsis diagnosis protocol it significantly reduces length of stay for IntelliSep tested patients, resulting in a savings of $1,429 per patient..

Cytovale目前正在与选定的早期访问合作伙伴合作，将IntelliSep测试整合到他们的ED筛查过程中。洛杉矶巴吞鲁日的一家大型学术医疗中心，也是该测试的早期采用者，湖区圣母医疗中心最近的数据发现，当IntelliSep早期被纳入ED脓毒症诊断方案时，它可以显着缩短IntelliSep测试患者的住院时间，从而为每位患者节省1429美元。。

About Cytovale®

关于Cytovale®

Cytovale is committed to improving human health by pioneering early detection technologies powered by insightful assessment of immune activation. Comprised of an extraordinary team of life scientists, engineers, clinicians, and dreamers, Cytovale intends to accelerate the time it takes to get from triage to life-saving therapies.

Cytovale致力于通过开创早期检测技术来改善人类健康，该技术由对免疫激活的深入评估提供支持。Cytovale由一群杰出的生命科学家、工程师、临床医生和梦想家组成，旨在加快从分流到挽救生命的治疗所需的时间。

Learn more about Cytovale and request to implement IntelliSep® in your hospital or care setting through cytovale.com. For updates, follow Cytovale on LinkedIn and X..

了解有关Cytovale的更多信息，并通过Cytovale.com请求在您的医院或护理环境中实施IntelliSep®。有关最新信息，请在LinkedIn和X上关注Cytovale。。

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