Clinical Information

For patients with hematuria or other reasons to suspect bladder cancer, an accurate, non-invasive test for bladder cancer can provide peace of mind for patients and valuable treatment direction for clinicians.

When combined with other diagnostic methods, urine-based laboratory tests like Cxbladder offer reliable results that are easy to obtain without placing additional stress on your patients.

What Is Cxbladder?

Cxbladder is a family of non-invasive molecular diagnostic laboratory tests optimized to help you assess the probability that your patient has bladder cancer. These tests give you actionable results to make a meaningful difference in your patients'treatment.

We offer three types of bladder cancer urine tests to serve a range of patient needs:

• Cxbladder Triage: A test with high negative predictive value designed to quickly rule out bladder cancer in low-risk patients with hematuria.
• Cxbladder Detect: A bladder cancer test that complements cystoscopy and other diagnostic procedures, aimed at detecting early bladder cancer with high accuracy.
• Cxbladder Monitor: A negative predictive test that offers high sensitivity and an actionable alternative to invasive surveillance procedures regularly endured by bladder cancer survivors.

With a single small, easy-to-obtain urine sample, Cxbladder can rule out or detect the presence of bladder cancer. Results become available seven business days after our lab receives the sample.

How Do Cxbladder Tests Work?

Research shows that some messenger RNA (mRNA) biomarkers appear in higher concentration in the urine of patients with bladder cancer compared to patients negative for the disease. Cxbladder tests predict a patient's probability of bladder cancer by measuring the levels of these biomarkers in a five-milliliter sample of mid-stream urine.

We test for five genetic biomarkers related to bladder cancer:

• MDK, which affects migration and angiogenesis in cancer cells
• HOXA13, which affects cell differentiation
• CDC2 (CDK1), which is essential to mitotic cell cycle and cell proliferation
• IGFBP5, which inhibits cell apoptosis
• CXCR2, which moderates non-malignant inflammation and causes false positives

When we receive a patient urine sample collected using our provided sampling system, we extract and purify the mRNA present to obtain test results. We first use a Reverse Transcription quantitative Polymerase Chain Reaction to convert the RNA to DNA. Then, we amplify the DNA using a temperature adjustment cycle.

Finally, we use a fluorescent probe to detect the number of copies of each DNA marker and use these results to calculate the patient's probability of urothelial carcinoma (UC).

How Does Cxbladder Benefit Patients?

The Cxbladder system has been clinically tested and validated, and compared to other bladder cancer tests and procedures, Cxbladder offers clinicians and their patients non-invasive testing that delivers actionable results.

Cxbladder benefits patients by providing test results that are:

• Reliable: More reliable and objective than many other urine-based tests such as cytology. Cxbladder utilizes high sensitivity and Negative Predictive Value to provide accurate results.1,2
• Efficient: Non-invasive and pain-free, Cxbladder provides a complete sampling system for collection of the patient’s urine sample and shipment to our laboratory.
• Actionable: Cxbladder provides actionable results to facilitate the early detection of bladder cancer by either helping to rule out the disease or to complement other diagnostic procedures and tests.
• Credible: Over 10 years of research has identified the five specific messenger RNA (mRNA) biomarkers that represent a bladder cancer signature in our tests.3 Cxbladder has been validated by a multicenter clinical study published in a highly respected peer-reviewed journal.

For patients with a history of bladder cancer, Cxbladder can significantly improve quality of life by reducing the need for invasive and uncomfortable monitoring procedures while maintaining safety and quality of care.

Learn More About Cxbladder Today

Choosing a clinical bladder cancer test is one of the first ways you serve patients with symptoms of UC, so it's important to select a testing system you can count on. The accurate results obtained using Cxbladder can help you make confident treatment decisions and give your patients peace of mind.

For more information on the full suite of Cxbladder cancer testing products available, get in touch with one of our representatives today.

• References

  Cxbladder was developed by a company whose passion and focus is cancer diagnostics and prognostics to improve patient outcomes. See our full list of clinical publications.

  Pacific Edge is responsible for the development and determination of the performance characteristics for Cxbladder. Because Cxbladder is a Laboratory Developed Test (LDT), Cxbladder has not been cleared or approved by the US Food and Drug Administration (FDA).