IRVINE, Calif., May 3, 2024 /PRNewswire/ -- VESICA HEALTH, INC., a leading multi-omics liquid biopsy company dedicated to improving the management of hematuria patients and the early detection of bladder cancer, today announced the launch of its laboratory-developed AssureMDx™ test.

加利福尼亚州欧文市，2024年5月3日/PRNewswire/-VESICA HEALTH，INC.，一家致力于改善血尿患者管理和膀胱癌早期发现的领先多组学液体活检公司，今天宣布推出其实验室开发的AssureMDx™测试。

Vesica Health Launches AssureMDx for Clinical testing

Vesica Health推出AssureMDx进行临床测试

Christopher Thibodeau, Chief Executive Officer of Vesica Health, expressed his enthusiasm, stating, 'We are delighted to officially introduce AssureMDx for patient testing. With an extensive evidence dossier of over 22 peer-reviewed publications, including three clinical validation studies, coupled with the recent successful completion of our analytical validation, we stand prepared to empower hematuria patients and their physicians with this vital tool for enhancing patient care.'.

Vesica Health首席执行官克里斯托弗·蒂博多（ChristopherThibodeau）表达了他的热情，他说：“我们很高兴正式推出AssureMDx用于患者检测。凭借超过22篇同行评审出版物的广泛证据档案，包括三项临床验证研究，再加上我们最近成功完成的分析验证，我们准备为血尿患者及其医生提供这一重要工具，以加强患者护理。”。

Laura Caba, MPH, President of Vesica Health, underscored the significance of this innovation, declaring, 'We are reshaping the landscape of early bladder cancer detection and fulfilling our commitment to elevating patient care and clinical outcomes.'

Vesica Health总裁劳拉·卡巴（LauraCaba）强调了这项创新的重要性，她宣称，“我们正在重塑早期膀胱癌检测的格局，并履行我们对提高患者护理和临床结果的承诺。”

AssureMDx represents a significant leap forward in bladder cancer diagnostics, offering unparalleled accuracy and reliability backed by rigorous scientific validation. This transformative test embodies Vesica Health's unwavering dedication to advancing the standard of care for hematuria patients worldwide..

AssureMDx代表了膀胱癌诊断领域的重大飞跃，在严格的科学验证支持下提供了无与伦比的准确性和可靠性。这项革命性的测试体现了Vesica Health坚定不移地致力于提高全球血尿患者的护理标准。。

About AssureMDx™

关于AssureMDx™

AssureMDx is a multi-omic noninvasive urine-based DNA test designed to transform the triage of hematuria patients. By providing physicians with a precise method for identifying patients at increased risk for bladder cancer, AssureMDx facilitates immediate urological referral and clinical evaluation when needed.

AssureMDx是一种基于多组学无创尿液的DNA检测，旨在改变血尿患者的分类。通过为医生提供准确的方法来识别膀胱癌风险增加的患者，AssureMDx有助于在需要时立即进行泌尿外科转诊和临床评估。

Importantly, the test also helps physicians effectively distinguish patients at very low risk, who may bypass invasive procedures and avoid unnecessary CT scans, thereby reducing potential radiation exposure risks. Backed by extensive research, the AssureMDx epigenetic and somatic biomarkers have been reported in 22 peer-reviewed studies involving over 6,000 patients, including multiple prospective clinical validation studies.

重要的是，该测试还可以帮助医生有效地区分风险非常低的患者，这些患者可能会绕过侵入性手术并避免不必要的CT扫描，从而降低潜在的辐射暴露风险。在广泛研究的支持下，AssureMDx表观遗传学和体细胞生物标志物已在22项同行评审研究中报道，涉及6000多名患者，包括多项前瞻性临床验证研究。

These studies consistently demonstrate the test's robust clinical performance, notably 0.96 AUC (area under the receiver operating characteristic curve), 99% Negative Predictive Value (NPV), and 96% Sensitivity for the detection of bladder cancer in hematuria patients. Moreover, AssureMDx will provide urologists a noninvasive means to monitor bladder cancer patients at heightened risk of recurrence following treatment, thereby enhancing patient management and improving outcomes..

这些研究一致证明了该测试具有强大的临床表现，特别是0.96 AUC（受试者工作特征曲线下面积），99%阴性预测值（NPV）和96%的血尿患者膀胱癌检测灵敏度。此外，AssureMDx将为泌尿科医生提供一种无创手段，用于监测治疗后复发风险较高的膀胱癌患者，从而加强患者管理并改善预后。。

About Vesica Health, Inc.

关于Vesica Health，Inc。

At Vesica Health, our mission is clear: to revolutionize the management of hematuria patients, enhance the early detection of bladder cancer, and improve patient survival. Hematuria, characterized by blood in the urine, affects an estimated 17 million (1-in-5) adult Americans annually, serving as the most common symptom of bladder cancer.

在Vesica Health，我们的使命是明确的：彻底改变血尿患者的管理，加强膀胱癌的早期发现，并提高患者的生存率。血尿以尿液中的血液为特征，每年影响约1700万（1/5）成年美国人，是膀胱癌最常见的症状。

Despite guideline recommendations, only 12% of patients are referred to urology for clinical evaluation, resulting in approximately 20,000 diagnoses missed each year. Delayed detection leads to later-stage disease and increased mortality rates. Conventional diagnostic methods like cytology and cystoscopy, while widely used, suffer from lower sensitivity and often fail to detect bladder cancer.

尽管有指南建议，但只有12%的患者被转诊至泌尿科进行临床评估，导致每年约有20000例诊断漏诊。延迟检测会导致晚期疾病和死亡率增加。传统的诊断方法，如细胞学和膀胱镜检查，虽然被广泛使用，但灵敏度较低，往往无法检测出膀胱癌。

Moreover, the fear of undetected cancer prompts a high rate of CT scans, exposing patients to unnecessary radiation and an increased risk of secondary cancer later in life. Drawing from 20 years of advanced multi-omics research in bladder cancer detection, AssureMDx is a clinically validated, noninvasive test that helps improve the evaluation of hematuria, enhance early disease detection, and enable effective recurrence monitoring.

此外，对未被发现的癌症的恐惧促使CT扫描率很高，使患者暴露于不必要的辐射中，并增加了晚年继发癌症的风险。从20年来在膀胱癌检测方面的先进多组学研究中汲取经验，AssureMDx是一种经过临床验证的无创测试，有助于改善血尿评估，增强早期疾病检测，并实现有效的复发监测。

For more information on our groundbreaking initiatives, visit www.vesicahealth.com..

有关我们开创性举措的更多信息，请访问www.vesicahealth.com。。

For more information:

有关更多信息：

Vesica Health Corporate Communications

Vesica Health公司通讯

public.relations@vesicahealth.com

public.relations@vesicahealth.com

This company announcement contains forward-looking statements and estimates with respect to the anticipated future performance of Vesica Health and the market in which it operates. Such statements and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable but may not prove to be correct.

本公司公告包含有关Vesica Health及其运营市场的预期未来业绩的前瞻性声明和估计。此类声明和估计基于对已知和未知风险、不确定性和其他因素的假设和评估，这些假设和评估被认为是合理的，但可能不正确。

Actual events are difficult to predict, may depend upon factors that are beyond the company's control, and may turn out to be materially different. Vesica Health expressly disclaims any obligation to update any such forward-looking statements in this announcement to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based unless required by law or regulation.  This company announcement does not constitute an offer or invitation for the sale or purchase of securities or assets of Vesica Health in any jurisdiction.

实际事件很难预测，可能取决于公司无法控制的因素，并且可能会产生实质性差异。除非法律或法规要求，否则Vesica Health明确否认有义务更新本公告中的任何此类前瞻性声明，以反映其对此类声明的期望的任何变化，或任何此类声明所依据的事件、条件或情况的任何变化。本公司公告不构成在任何司法管辖区出售或购买Vesica Health证券或资产的要约或邀请。

No securities of Vesica Health may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. securities laws..

未经《1933年美国证券法》（修订版）登记，或未遵守该法案的豁免规定，以及任何适用的美国证券法，不得在美国境内发售或出售Vesica Health的任何证券。。

NOTE: The Vesica Health wordmarks and logos, including Vesica Health, and AssureMDx are trademarks or registered trademarks of Vesica Health, Inc. All other trademarks and service marks are the property of their respective owners.

注意：包括Vesica Health和AssureMDx在内的Vesica Health文字标记和徽标是Vesica Health，Inc.的商标或注册商标。所有其他商标和服务标记均为其各自所有者的财产。

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SOURCE Vesica Health

来源Vesica Health