Innovative Bladder Cancer Tests
The CertNDx™ Bladder Cancer Assays are a suite of molecular diagnostic tests that can assist physicians in the diagnosis, detection and management of bladder cancer. Molecular diagnostic tests analyze genetic content (i.e. genes and proteins) for disease information. Specific biomarkers have been shown to be associated with different cancers. Although currently available tests can analyze biomarkers for disease information there are limitations on how it is identified which can result in a misdiagnosis.
At Predictive Biosciences we have developed a new approach to molecular diagnostic tests that allows physicians to triage patients to help determine the priority of treatment. Our goal is to give your doctor more information so unnecessary procedures might be eliminated or treatment accelerated. We know with answers comes peace of mind, and we are committed to improving the way cancer is diagnosed.
When Could a CertNDx Test Be Used?
The CertNDx Bladder Cancer Assay can be used for patients suffering from hematuria (blood in the urine). A urine sample will be collected and sent to our laboratory for processing. Based on the detection of biomarkers, the likelihood of bladder cancer can be determined.
Test results for our urine testing fall into 3 categories:
- Negative - high likelihood to be disease-free and may be excluded from further evaluation.
- Positive - high likelihood of cancer and should receive accelerated intervention.
- Intermediate - high likelihood to be disease-free but due to an elevated biomarker cancer cannot be ruled out with certainity. The scheduled standard of care is recommended.
For patients that have undergone a bladder tumor removal, we have a CertNDx molecular grading test available. Molecular grading is an objective tool to determine the seriousness of a tumor. The standard process for evaluating a tissue sample is a pathological review which requires a pathologist to look at the sample under a microscope to arrive at a diagnosis. Molecular grading is a helpful complement for your doctor to feel confident in your diagnosis.
The CertNDx Bladder Cancer Assay can also be used to monitor for recurrence (a return of the cancer). In a very similar process to hematuria assessment a urine sample is collected and analyzed to help determine whether the bladder cancer has recurred.