Bladder CARE™
A simple, urine-based epigenetic test for the early detection, surveillance, and prognosis assessment in bladder cancer and upper tract urothelial carcinoma (UTUC).
Pangea Laboratory and Unilabs partner to launch BladderCare™ assay in Switzerland, advancing non-invasive cancer diagnostics in Europe.
BLADDER CARE™
Non-invasive, Early Bladder Cancer and UTUC Detection and Surveillance Test
Bladder CARE™ test is designed to integrate seamlessly into clinical workflows, providing timely molecular information to support patient evaluation and ongoing management. Bladder CARE™ is intended for the quantitative detection of bladder cancer and upper tract urothelial carcinoma (UTUC) DNA from urine samples. The test is intended for use alongside standard diagnostic procedures and may help inform clinical decision-making for patients with suspected of bladder cancer and UTUC.
Non-Invasive
simple urine sample collected at-home or in-office
Quantitative
measures how much bladder cancer signal
Highly Accurate
the only test with both sensitivity and specificity >93%
Early Cancer Detection
up to 7 months earlier than standard of care (cystoscopy)
Urothelial cancers (bladder cancer and UTUC) are significant clinical and economic burden.
Bladder cancer is the 4th most commonly diagnosed cancers in men in the United States, with up to 65,000 new cases annually in USA. There are over 2 million people globally living with bladder cancer, with over 25% of cases detected at a late stage.
Non-muscle-invasive bladder cancer accounts for the majority of cases and is associated with high recurrence rates, requiring ongoing surveillance over time. Current guidelines rely heavily on cystoscopy, an invasive procedure that can be burdensome for patients and resource-intensive for healthcare systems.
Upper tract urothelial carcinoma (UTUC), while less common, presents additional diagnostic challenges and often requires more invasive procedures to confirm disease presence.
There is a clear need for non-invasive tests that can complement standard care by providing additional molecular information to support evaluation and ongoing monitoring.
BLADDER CARE™
CLINICAL PERFORMANCE
Bladder CARE™ demonstrated 93.5% sensitivity and 92.6% specificity in performance studies evaluating the detection of bladder cancer and UTUC-associated epigenetic signals.
Non-Invasive Testing
Bladder CARE™ provides a urine-based approach to bladder cancer and UTUC testing without the need for invasive procedures. The test is designed to integrate into standard care and support evaluation and ongoing monitoring.
At-Home Sample Collection
Bladder CARE™ can be used with an optional at-home urine collection kit, helping simplify sample collection for patients undergoing surveillance. This approach reduces the need for frequent in-office visits while supporting continued monitoring.
High Analytical Sensitivity
Bladder CARE™ is designed to detect bladder and UTUC cancer-associated epigenetic signals at low concentrations, supporting early molecular insight and longitudinal monitoring when used alongside standard clinical assessment.
What Your Results Mean
Bladder CARE™ results are reported using a proprietary algorithm that generates a quantitative Bladder CARE™ Index (BCI), reflecting the relative abundance of bladder cancer and UTUC-associated epigenetic signals detected across a multiplex panel of DNA methylation markers (including TRNA-Cys, SIM2, and NKX1-1). Based on predefined thresholds, results are categorized as Negative, Low Positive, or Positive.
While Low Positive results capture a meaningful proportion of cancer cases, they are associated with lower disease specificity and are more frequently observed in patients with lower-grade or lower-volume disease, whereas Positive results are more strongly associated with higher disease burden. This stratified reporting supports more personalized clinical interpretation when used alongside standard diagnostic and surveillance practices.
Bladder CARE™ supports multiple clinical uses across key points of bladder cancer care
Initial Evaluation
Supporting assessment in patients with suspected disease
Diagnostic Workup
Used alongside standard diagnostic procedures
Risk Stratification
Providing molecular insight to support care planning
Ongoing Monitoring
Supporting surveillance and recurrence assessment
How Bladder CARE™ Is Offered
Reference Lab Service
Testing performed through Pangea Laboratory
- Urology clinics and practices
- Primary care and internal medicine
- Urology divisions within hospital systems
Diagnostic Kit
Reagent Kits
- Urology-specific clinical laboratories
- Large urology group practices
- Regional and international laboratory partners
Discover Pangea Laboratory's vision for the future of healthcare
Bladder CARE™ Test:
From Sample Collection to Results
Step 1
Sample Collection
Urine samples for Bladder CARE™ can be collected either at home or in a clinical setting using the Urine Collection Kit.
Following collection, samples are stabilized using the provided preservation reagent, which maintains urine DNA integrity at ambient temperature for up to 28 days, enabling flexible transport to the laboratory.
Step 2
Sample Shipment to the Laboratory
Stabilized samples are returned to Pangea Laboratory for processing using standard shipping procedures.
Step 3
Testing Performed At Lab
DNA is extracted from the urine sample and analyzed using a multiplex, qPCR-based assay targeting bladder cancer-associated epigenetic markers. Results are interpreted using a proprietary algorithm.
Step 4
Results Reporting
Results are reported as a Bladder CARE™ Index (BCI) and categorized as Negative, Low Positive, or Positive to support clinical interpretation when used alongside standard care.
(The) Bladder Care™ Test may be useful in monitoring and predicting response to neoadjuvant therapy in patients with muscle invasive bladder cancer.
SAUM GHODOUSSIPOUR, MD
The Science of Bladder Care™
Bladder Care™ Abstract, Posters and Presentations
Utility of a Urine-Based DNA Methylation Test for Surveillance in Non-Muscle Invasive Bladder Cancer: A Pilot Study by Ladi-Seyedian, S., Ghoreifi, A., et al (2022) – Presented at the American Urological Association General Meeting 2022, and won 3rd place at the Miley B. Wesson Resident Essay Contest t the Western Section American Urological Association 2022
A Urine-Based DNA Methylation Marker Test to Detect Upper Tract Urothelial Carcinoma: A Pilot Study by Ghoreifi, A., Ladi-Seyedian, S., et al. (2021) – Presented at the American Urological Association General Meeting 2021 and at the Western Section American Urological Association 2022
Urine Biomarkers for the Detection of Urothelial Carcinoma by Daneshmand, S. (2021) – Presented at Grand Rounds in Urology International Bladder Cancer Update 2021
A Urine-Based DNA Methylation Test to Monitor Response to Neoadjuvant Chemotherapy in Bladder Cancer by Ghodoussipour, S., Basin, M., et al. (2020) – Presented at the American Urological Association General Meeting 2020
Also available in Spanish and Portuguese
Bladder care epigenetic test allows the sensitive early detection of bladder cancer from urine samples by Piatti, P., Suwoto, M., et al. (2020) – Presented at Proceedings of the Annual Meeting of the American Association for Cancer Research 2020
Use of Biomarkers in Diagnostic Testing
DNA Methylation Cancer Biomarkers: Translation to the Clinic by Locke, W., Guanzon, D., et al. (2019)
While cystoscopy remains a standard procedure for confirming bladder cancer, it is invasive and can place a burden on patients when used repeatedly for surveillance. Bladder CARE™ is designed to provide complementary, non-invasive molecular information that may support clinical evaluation and ongoing monitoring when used alongside standard diagnostic practices. By offering an additional source of insight, Bladder CARE™ may help clinicians prioritize follow-up and focus attention where it is most needed.
Bladder CARE™ is offered as a laboratory-developed test (LDT). Physicians and patients interested in learning more are encouraged to contact our team.
Evaluation Access for Clinicians
Pangea Laboratory is offering qualified clinical partners limited evaluation access to Bladder CARE™. This program allows clinicians to gain hands-on experience with the test within their existing diagnostic and surveillance workflow
For additional details regarding eligibility and participation, please contact our team.
IMPORTANT SAFETY INFORMATION AND PRODUCT LIMITATIONS
Results should be interpreted by a trained professional in conjunction with the patient’s history and clinical signs and symptoms, and epidemiological risk factors. Results analysis and interpretation guidelines may be subject to updates based on future clinical data.
False-negative results may arise from the improper collection, shipping, storage, and/or purification of the specimen. False-positive results may arise from the presence of tumors other than bladder cancer or UTUC. The performance of this test was established using voided urine.
Negative results do not preclude bladder cancer or UTUC and should not be the sole basis of a patient’s treatment/management or public health decision. Follow-up testing should be performed according to the healthcare provider’s recommendations.
Bladder CARE™ Disclaimers
Limitation of Procedures
Optimum performance of this kit requires urine specimens collected and stabilized in Urine Conditioning Buffer (Zymo Research, cat. D3061-1-140), extracted using the Quick-DNA Urine Kit (Zymo Research, cat. D3061) and analyzed using the Bio-Rad CFX96 Touch™ Real-Time PCR Detection System and the Bio-Rad CFX Maestro™ 1.1 Version 4.1.2433.1219 software (Bio-Rad). Variations in any component of the validation workflow indicated above may results in changes in performance characteristics of the Bladder CARE™ Kit.
Detection of bladder cancer-specific DNA may be affected by sample collection, stabilization, and extraction methods, patient factors, and/or stage of the disease. If you wish to use a different sample collection/preservation, extraction, and/or analysis system, please contact Zymo Research, and perform a cross-validation experiment.
A false negative result may occur if a specimen is improperly collected, transported, stored, handled and/or purified. False negative results may also occur if amplification inhibitors are present in the specimen or if inadequate numbers of cancer cells and/or DNA are present in the specimen.
False-positive results may arise from presence of tumors other than bladder cancer. The performance of this test was established using voided urine.
First-void, mid-stream, and first-morning urine, as well as urine collected from catheterized patients and tissue samples are also considered acceptable specimen, but performance has not been established.
Bladder CARE™ test failure may be caused by lubricating agents added to the urine samples during patient’s catheterization procedures, and by the presence of mucin in the sample at concentration at or above 0.1%. The impacts of drugs, anticancer treatments (including chemo- and immunotherapeutic agents), antibiotics, or immunosuppressant drugs on Bladder CARE™ test performance have not been evaluated.
Using less than 5 ng of DNA/reaction may increase the chance of inaccurate results as the number of DNA molecules analyzed may not be sufficient for accurate detection. DNA subjected to thermal or chemical denaturation is not compatible with Bladder CARE™ analysis. DNA isolated from samples treated with crosslinking agents (e.g. FFPE samples) is not compatible with Bladder CARE™ analysis.
To ensure the reproducibility of Bladder CARE™ test each real-time PCR instrument needs to be qualified with standard samples provided by Zymo Research Corp.
As with any molecular test, genomic mutations or deletions affecting the target regions detected by the Bladder CARE™ test could affect primer and/or probe binding resulting in failure to detect the presence of bladder cancer.
Results should be interpreted by a trained professional in conjunction with the patient’s history and clinical signs and symptoms, and epidemiological risk factors. Results analysis and interpretation guidelines may be subjected to updates based on future clinical data.
Negative results do not preclude bladder cancer and should not be the sole basis of a patient treatment/management or public health decision. Follow up testing should be performed according to healthcare provider’s recommendations.
Members of the testing laboratory will be trained to perform this assay and competency will be assessed and documented.
This test cannot rule out diseases caused by other types of cancer