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.
Vesica Health Launches AssureMDx for
Clinical testing
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."
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."
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.
About 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. 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. 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.
About 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. 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. 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. For more information on our
groundbreaking initiatives, visit www.vesicahealth.com.
For more information:
Vesica Health Corporate
Communications
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. 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. 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.
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.
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SOURCE Vesica Health