Novel Assay Outperforms Urine Cytology and FDA-Approved Tests in Detecting Bladder Cancer and UTUC

Bladder cancer ranks as the fourth most prevalent cancer among males, with about 70% of all cases being non-muscle-invasive bladder cancer, which generally has positive survival rates. Despite this, bladder cancer's high recurrence rates, ranging between 60 to 70%, calls for rigorous monitoring. Current diagnostic approaches can lead to considerable discomfort for patients or might result in delayed or inaccurate results, underscoring the urgent need for dependable, non-invasive testing methods. This is especially critical for upper tract urothelial carcinoma (UTUC), closely linked to bladder cancer but with a more unfavorable prognosis and traditionally only identifiable through invasive procedures. Now, a novel, non-invasive bladder cancer detection test marks a promising advancement for the early detection of urothelial cancers.

The Bladder CARE Assay by Pangea Laboratory (Tustin, CA, USA) offers a non-invasive, urine-based method for quantitatively diagnosing bladder cancer and UTUC in individuals presenting with hematuria and suspected cancer. This assay detects the methylation levels of three DNA biomarkers specific to urothelial cancer in a single qPCR reaction. It significantly surpasses traditional cytology and other FDA-endorsed tests, boasting detection sensitivities and specificities of 93.5% and 92.6% for bladder cancer, 96% and 88% for UTUC, and 89% sensitivity for carcinoma in-situ, which is notoriously challenging to identify. The test comprises a simple urine collection kit that stabilizes the specimen for room-temperature shipping, further easing the burden on patients and healthcare systems.

Remarkably, the Bladder CARE Assay's high diagnostic precision and negative predictive value for UTUC, demonstrating 96.7% sensitivity for high-grade and 100% for low-grade tumors, significantly surpass the 43.3% and 0.0% respectively offered by urine cytology. Its quantitative approach distinguishes the Bladder CARE Assay from other diagnostics, potentially providing clinicians with crucial insights into patient responses to cancer therapies. Pangea Laboratory has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA) for its non-invasive Bladder CARE Assay and is set to initiate multicenter clinical studies, moving towards obtaining premarket approval for the assay.

"The FDA's recognition of the Bladder CARE Assay validates its potential to reshape cancer diagnostics, making effective and patient-friendly detection a reality," said Dr. Larry Jia, Founder and CEO of Pangea Laboratory.

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