Bringing Clarity to Clinical Decisions
Early detection remains essential to improving outcomes for bladder cancer patients.
IRVINE, CA – January 7, 2024 – VESICA HEALTH, INC., a pioneering diagnostics company transforming bladder cancer detection and hematuria management, proudly announces that its Irvine-based laboratory has earned accreditation by the College of American Pathologists (CAP). This achievement underscores Vesica Health’s dedication to advancing early detection of bladder cancer, ensuring the highest standards of laboratory excellence, and improving outcomes for patients and healthcare providers alike.
“Securing CAP Accreditation is the culmination of an exceptional year of growth and innovation at Vesica Health,” said Christopher Thibodeau, CEO of Vesica Health. “This milestone reflects our team's commitment to providing physicians and patients with the most reliable and advanced diagnostic solutions.”
The CAP Accreditation is awarded after a comprehensive evaluation of laboratory processes, personnel qualifications, equipment, and quality management systems, ensuring compliance with the highest industry standards. This milestone underscores Vesica Health’s dedication to precision diagnostics and its commitment to delivering reliable, high-quality results to healthcare providers and their patients.
Building on its California State Department of Health Clinical Laboratory License and CLIA Certification, Vesica Health's CAP Accreditation underscores a transformative year for the company. In 2024, Vesica successfully launched its flagship product, AssureMDx, on May 3, providing a critically needed non-invasive diagnostic tool for early bladder cancer detection. The company also established state-of-the-art laboratory operations in Irvine, CA, and forged key research collaborations with academic and clinical partners to develop next-generation diagnostics integrating advanced biomarkers and multi-omics technologies. These achievements reflect Vesica Health’s commitment to precision diagnostics, regulatory excellence, and improving patient outcomes, positioning the company as a leader in the field.
AssureMDx is a proprietary, non-invasive urine-based DNA test addressing critical gaps in hematuria evaluation and early bladder cancer detection. With its successful launch on May 3, 2024, AssureMDx addresses critical gaps in bladder cancer detection through its industry-leading accuracy. Hematuria impacts 17 million U.S. adults annually, yet only 12% receive urological evaluation, leading to 20,000 missed bladder cancer diagnoses each year. Backed by 22 peer-reviewed studies involving over 6,000 patients, AssureMDx delivers industry-leading accuracy with a 0.96 AUC, 99% Negative Predictive Value (NPV), and 96% Sensitivity for the presence of bladder cancer. Traditional methods like cytology and cystoscopy suffer from limited sensitivity, while overuse of CT scans increases radiation exposure and the risk of secondary cancers. AssureMDx provides a precise solution, enabling timely urology referrals for high-risk patients and sparing low-risk patients from unnecessary invasive procedures and CT scans. Additionally, the test supports non-invasive monitoring for cancer recurrence, improving long-term outcomes. By reducing unnecessary procedures and improving healthcare efficiency, AssureMDx not only enhances patient outcomes but also delivers significant cost savings to healthcare systems. This innovative diagnostic tool exemplifies Vesica Health’s mission to transform bladder cancer care through early detection, precision diagnostics, and improved patient outcomes.
Vesica Health is a pioneering diagnostics company at the forefront of transforming bladder cancer detection and hematuria management. Positioned as a growth-stage company, Vesica has achieved significant milestones, including securing CAP Accreditation, a California State Department of Health Clinical Laboratory License, and CLIA certification for its Irvine-based laboratory. Building on over 20 years of advanced multi-omics research, Vesica launched its flagship product, AssureMDx, a clinically validated non-invasive diagnostic test with 96% sensitivity for the presence of disease, offering unparalleled precision for early bladder cancer detection and recurrence monitoring. With a strong operational foundation, Vesica Health is scaling its laboratory operations, expanding clinical adoption of AssureMDx, and pursuing partnerships to extend market reach. Looking ahead, the company is focused on driving commercialization, advancing its R&D pipeline, and exploring global expansion to address the unmet needs of millions of hematuria patients worldwide. Vesica Health represents a compelling investment opportunity in cutting-edge diagnostics with the potential to significantly impact patient care and healthcare systems. For more information, visit www.vesicahealth.com.
About the College of American Pathologists
The College of American Pathologists is a globally recognized leader in laboratory quality assurance and accreditation. CAP accreditation is regarded as the gold standard for laboratory excellence, representing a commitment to quality, accuracy, and patient safety.
For investment and partnership inquiries, or to learn more about AssureMDx, please contact Vesica Health Corporate Communications at: 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.
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