Pangea® Laboratory announced today the licensing of a new urine-based Laboratory Developed Test (LDT) for bladder cancer detection. Commercialized and sold under the name Bladder CARE™, the test is non-invasive, cost-effective and epigenetic-based.
Urine samples for the Bladder CARE™ test can be collected comfortably at home or at the doctor's office and mailed to Pangea® Laboratory for analysis.
Bladder cancer ranks as the fifth most common malignancy in the U.S.* The gold standard technique to diagnose bladder cancer is cystoscopy, which allows the doctor to directly inspect the bladder for the presence of a tumor. Cystoscopy is routinely used to detect bladder cancer in symptomatic patients and for the long-term monitoring of patients with bladder cancer history. However, because of its invasiveness and cost, cystoscopy is not used to screen the population with increased risk of bladder cancer (like smokers and specific categories of workers). A simple, non-invasive and cost-effective test like Bladder CARE™ is therefore needed.
Pangea® Laboratory conducted a pre-clinical collaborative study with Zymo Research, in which 182 urine samples were analyzed using Bladder CARE™. The cohort consisted of 97 urine specimens collected from bladder cancer patients and 85 healthy control samples. The study showed that Bladder CARE™ has 93.8% sensitivity, 85.9% specificity, 88.4% positive predictive value (PPV) and 92.4% negative predictive value (NPV). The same study also revealed that Bladder CARE™ has a very high sensitivity, not only for high-grade bladder cancer but also for low-grade cases (88.2% and 97.4% sensitivity for bladder tumors with a Gleason score of G1 and G2, respectively) making Bladder CARE™ a powerful tool for early bladder cancer detection. The data demonstrate that Bladder CARE™ is one of the most sensitive and accurate tests for bladder cancer detection on the market. In addition, Bladder CARE™ has the potential to significantly improve the monitoring of bladder cancer also for at-risk categories that are not usually included in the screening program.
The results of the pre-clinical study were presented at the Sanford Burnham Prebys Medical Discovery Institute's 29th Annual Symposium held on October 29, 2018, in La Jolla, Calif. The symposium showcased recent research on the epigenome and its role in the control of development, aging and disease.
Dr. Paolo Piatti, Project Manager at Pangea® Laboratory, explained, "In addition to its superior sensitivity, Bladder CARE™ is completely non-invasive. This advantage, in combination with the simple at-home sample collection, makes this test extremely patient-friendly and allows physicians to streamline the patients' monitoring process."
"The Bladder CARE™ test allows the precise measurement of the methylation level of bladder cancer-specific biomarkers," said Dr. Larry Jia, Founder and Director of Zymo Research. "The test is extremely simple, rapid and cost-effective."
For more information about the Bladder CARE™ test, go to http://pangealab.com