Bringing Clarity to Clinical Decisions
Early detection remains essential to improving outcomes for bladder cancer patients.
About Vesica Health
Our company has translated proven multi-omic technology into a well-validated, clinically actionable test that improves the evaluation of hematuria and the early detection of bladder cancer.​​
Our mission is to help physicians identify hematuria patients at increased risk for bladder cancer, who may benefit from immediate referral to urology and clinical evaluation.​
Our patented, noninvasive urine-based AssureMDx test also helps physicians accurately distinguish hematuria patients at very low risk for bladder cancer, who may safely avoid invasive procedures.
Providing physicians and patients with highly sensitive and specific, noninvasive tests to transform the management of hematuria and improve the early detection and treatment of bladder cancer.
Hematuria
Hematuria is the leading symptom of bladder cancer, with ~5% to 20% of patients diagnosed upon cystoscopy, so it is important to understand the cause.
Bladder Cancer
In the US, bladder cancer is the 6th most frequent cancer. Most patients are 55 years and older, and it is 4 times more common in males than females.
AssureMDx
AssureMDx is a simple, noninvasive urine test that can help doctors determine a patient's risk for harboring bladder cancer.
Hematuria is the Leading Symptom of Bladder Cancer
It is estimated that 17 million Americans have hematuria, with 1 in 5 US adults having blood detected upon urinalysis. (1, 2)
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Over 85% of bladder cancer patients present with hematuria as the initial symptom. (3)
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Hematuria guidelines recommend that all intermediate and high-risk patients be referred to urology for clinical evaluation. (4)
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However, only ~12% of patients are actually referred to a urologist. (5)
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With a dismal 38% survival rate for later stage bladder cancer, 1-in-4 patients are diagnosed too late. (6)
References:
1) Halpern et al, JAMA Int Med 2017, 2) Jubber et al Eur Uro 2020, 3) Shirodkar et al, Expert Rev Anticancer Ther. 2008, 4) Waldu et al, J Uro 2021, 5) Ghandour et al, Bladder Cancer 2019, 6) NCI SEER 2022
Bladder Cancer Statistics in US
Annually there are an estimated 84,870 new bladder cancer diagnoses leading to 17,420 deaths.
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According to the National Cancer Institute, nearly half of cases are diagnosed after the cancer has already started to spread—making it harder to treat.​
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Early-stage bladder cancer has a 5-year survival rate of nearly 98%
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When the cancer spreads beyond the bladder, survival drops to as low as 9%
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Catching bladder cancer early offers the best chance for cure.
Source: NCI SEER 2025
Gender Disparity Results
in Delayed Diagnosis
While males have a greater lifetime risk for developing bladder cancer, females with hematuria are less likely to be referred to urology than men. (1)
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Females are 2.5-fold (p < 0.001) more likely to require three or more primary care visits before referral to a urologist than males. (2)
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As a consequence, females are diagnosed with more advanced-stage disease and have poorer prognosis. (1)
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Delayed diagnosis is believed to contribute to higher stage disease and a 34% increased risk of mortality compared to males. (3)
References:
1) Ngo et al, BJU Int 2017, 2) Ghandour et al, Bladder Cancer 2019, 3) Barocas et al 2020
Hematuria & Bladder Cancer Detection
Hematuria, blood in the urine, is the most common symptom of bladder cancer. While only 5% to 10% of hematuria patients have bladder cancer, ~85% of bladder cancer patients present with hematuria.
When there is concern about a patient's risk for bladder cancer, a primary care physician may refer a hematuria patient to a urologist for clinical evaluation. The most common method to diagnose bladder cancer is a cystoscopy procedure, whereby a camera is inserted via the urethra to examine the inner lining of the bladder wall for lesions.
AssureMDx is a noninvasive, urine-based test which evaluates genomic changes associated with the presence of bladder cancer and can help identify high-risk patients who will benefit from clinical evaluation by a urologist. Importantly, the test also helps identify low-risk patients who may safely avoid invasive and potentially harmful diagnostic procedures.
Improving Risk Stratification and Early Detection
AssureMDx provides primary care physicians a noninvasive means to appropriately triage hematuria patients.
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AssureMDx uses a simple urine sample to evaluate the presence of specific DNA biomarkers shown to be present with bladder cancer.
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When the test is positive, hematuria patients are at increased risk for bladder cancer and should be referred to a urologist for clinical evaluation.
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When the test is negative, the patient is at very low risk for bladder cancer and may safely avoid invasive procedures.
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AssureMDx helps improve early detection of bladder cancer, provides greater peace of mind, and reduces healthcare expenses.
References:
1) van Kessel et al, J Uro 2016, 2) van Kessel et al J Uro 2017, 3) van Kessel et al, 2020 4) de Jong et al, Eur Uro Onc 2023
Leveraging Epigenetic & Somatic Mutation Analysis
AssureMDx is a proprietary multi-omic test that interrogates the DNA methylation status of OTX1, ONECUT2 and TWIST1 genes in combination with the somatic mutation status of FGFR3, TERT and HRAS genes for the detection of bladder cancer signal in a urine sample.
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AssureMDx combines the power of these DNA biomarkers with the addition of clinical risk factors to determine a patient's risk of having bladder cancer detected upon cystoscopy.
References:
1) van Kessel et al, J Uro 2016, 2) van Kessel et al J Uro 2017, 3) van Kessel et al, 2020 4) de Jong et al, Eur Uro Onc 2023
Clinically Validated Performance
Vesica Health's biomarkers & technology have been reported in:
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26 peer-reviewed, published studies
>8,500 patients
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AssureMDx has consistently delivered strong performance in sequential clinical validation studies:
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0.96 Area Under Curve
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96% Sensitivity
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99% Negative Predictive Value
References:
1) van Kessel et al, J Uro 2016, 2) van Kessel et al J Uro 2017, 3) van Kessel et al, 2020 4) de Jong et al, Eur Uro Onc 2023
AssureMDx Delivers Actionable Results
As reported in multiple peer-reviewed clinical validation studies, the AssureMDx test has demonstrated best-in-class performance with 96% Sensitivity, 99.6% Negative Predictive Value for the presence of bladder cancer.
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AssureMDx provides binary results to help physicians with clinical decisions:
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Identify hematuria patients at high-risk for bladder cancer who will benefit from immediate referral to urology for clinical evaluation.
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Triage high-risk hematuria patients following a negative cystoscopy to rule-out upper tract cancer* and avoid unnecessary CT scans.
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Monitor patients for bladder cancer recurrence following treatment.
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* Upper tract cancer is urothelial cancer in the upper urinary pyelocaliceal cavities and/or ureters above the bladder.
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References:
1) van Kessel et al, J Uro 2016, 2) van Kessel et al J Uro 2017, 3) van Kessel et al, 2020 4) de Jong et al, Eur Uro Onc 2023
AssureMDx Test Now Available
Get in Touch
Vesica Health, Inc.
5 Mason Lane
Suite #180
Irvine, California 92618
California State Department of Health Clinical Laboratory License: CDF-90001843
CLIA License: 05D2197032
CAP Accreditation: 9647012
For more information about Vesica Health and AssureMDx, please complete the following: