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About Vesica Health

Our company has translated 20 years of advanced multi-omic research in bladder cancer detection into well-validated, clinically actionable tests that improve the evaluation of hematuria and the early detection of bladder cancer.

Our mission is to transform the diagnosis and management of bladder cancer, helping 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 men than women.

AssureMDx

AssureMDx is a simple, noninvasive urine test that can help doctors determine a patient's risk for harboring bladder cancer.

Bladder image with RBCs

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)

Over 85% of bladder cancer patients present with hematuria as the initial symptom. (3)

Hematuria guidelines recommend that all intermediate and high-risk patients be referred to urology for clinical evaluation. (4)

However, only ~12% of patients are actually referred to a urologist. (5)

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 82,000 new bladder cancer cases leading to 17,000 deaths.

Based on National Cancer Institute SEER data, 46% of patients are diagnosed at later stages of disease. 

While 5 year survival for early-stage disease is 96%, once bladder cancer progresses to muscle invasive disease, survival is reduced to 55%. When cancer spreads beyond the bladder, survival drops to only 38%.

 

Early detection remains critical.

Source: NCI SEER 2022

Doctor holding bladder image.webp
Bladder Cancer_Woman

Gender Disparity Results
in Delayed Diagnosis

While men have a greater lifetime risk for developing bladder cancer than women, 1 in 27 versus 1 in 89, women with hematuria are less likely to be referred to urology than men. (1).

Women are 2.5-fold (p < 0.001) more likely to require three or more primary care visits before referral to a urologist than men. (2)

As a consequence, women are diagnosed with more advanced-stage disease and have poorer prognosis. (1)

Delayed diagnosis is believed to contribute to higher stage disease and a 34% increased risk of mortality compared to men. (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.

Hematuria - Urine Sample - Dipstick Test
Cystoscopy Performed on Male

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.

Urine Sample
AssureMDxTM - All Rights Reserved.png
Man with hematuria fearful of cystoscopy

Improving Risk Stratification and Early Detection

AssureMDx provides primary care physicians a noninvasive means to appropriately triage hematuria patients.

The AssureMDx test uses a simple urine sample to evaluate the presence of specific DNA biomarkers shown to be present with bladder cancer. 

When the test is positive, hematuria patients are at increased risk for bladder cancer and should be referred to a urologist for clinical evaluation.

When the test is negative, the patient is at very low risk for bladder cancer and may safely avoid invasive procedures.

The AssureMDx test helps improve early detection of bladder cancer, provides greater peace of mind, and reduces the associated healthcare expenses.

References:

1) 1) van Kessel et al, J Uro 2016, 2) van Kessel et al J Uro 2017, 3) de Jong et al, J Uro 2020

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.

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) de Jong et al, J Uro 2020

DNA Methylation - Epigenetic Image
Year
Authors
Journal
Subjects
2003
van Rhijn et al
Clinical Cancer Research
74
2005
van Oers et al
Clinical Cancer Research
92
2010
van der Aa et al
Journal of Urology
448
2010
Kompier et al
PLOS One
257
2010
Zuiverloon et al
Clinical Cancer Research
200
2010
Renard et al
European Urology
466
2011
Zuiverloon et al
BJU International
112
2011
Zuiverloon et al
Journal of Urology
18
2012
Kamidalla et al
European Urology
274
2013
Zuiverloon et al
Journal of Urology
136
2013
Bangma et al
European Urology
409
2013
Kandimalla et al
Clinical Cancer Research
445
2013
Yegin et al
DNA & Cell Biology
71
2013
van Kessel et al
Journal of Urology
70
2013
Beukers et al
PLOS One
169
2014
Allory et al
European Urology
468
2016
van Kessel et al
Journal of Urology
154
2017
Beukers et al
Journal of Urology
977
2017
van Kessel et al
Journal of Urology
200
2020
de Jong et al
Journal of Urology
838

Clinically Validated Performance

AssureMDx genes & technology have been validated and reported in:

20 peer-reviewed, published studies

 

>5,878 patients

 

0.96 Area Under Curve

96% Sensitivity

99% Negative Predictive Value

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.

AssureMDx provides binary results to help physicians with clinical decisions:

  • Identify hematuria patients at high-risk for bladder cancer who will benefit from immediate referral to urology for clinical evaluation.

  • Triage high-risk hematuria patients following a negative cystoscopy to rule-out upper tract cancer* and avoid unnecessary CT scans.

 

  • Monitor patients for bladder cancer recurrence following treatment.

 

* Upper tract cancer is urothelial cancer in the upper urinary pyelocaliceal cavities and/or ureters above the bladder.

References:

1) van Kessel et al, J Uro 2016, 2) van Kessel et al J Uro 2017, 3) de Jong et al, J Uro 2020

Patient presents with hematuria

AssureMDx Logo Blue

High Risk for Bladder Cancer

Recommend Cystoscopy & CT Scan

Very Low Risk for Bladder Cancer

Monitor

Female urologist and male bladder cancer patient

Optimizing Patient Management

AssureMDx helps physicians improve early detection, when there is the greatest opportunity for cure, especially for women who are routinely diagnosed at later stages of disease.

AssureMDx enables less extensive and invasive examination on patients at very low risk for bladder cancer, reducing morbidity and cost.

 

AssureMDx helps reduce unnecessary CT scans and potentially harmful exposure to radiation & contrast agents.

References:

1) van Kessel et al, J Uro 2016, 2) van Kessel et al J Uro 2017, 3) de Jong et al, J Uro 2020

AssureMDx Test Available in 2024 

Get in Touch

Vesica Health, Inc.

17595 Harvard Avenue

Suite C #10109

Irvine, California 92614

Phone: 949-787-0127

For more information about Vesica Health and AssureMDx, please complete the following:

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