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Pangea Laboratory Licenses Bladder Cancer Detection Test From Zymo Research

NEW YORK (GenomeWeb) – Pangea Laboratory said yesterday that it has licensed a urine-based laboratory-developed test for bladder cancer detection from Zymo Research.

Commercialized and sold under the name Bladder Care, the test uses qPCR to measure the methylation level of three bladder cancer-specific biomarkers in patient urine samples that can be collected at home or in a physician's office.

In a study presented at the Sanford Burnham Prebys Medical Discovery Institute Annual Symposium in October, Pangea and Zymo researchers used Bladder Care to analyze 182 urine samples — 97 urine specimens collected from bladder cancer patients and 85 healthy control samples. The study showed that Bladder Care has 93.8 percent sensitivity, 85.9 percent specificity, 88.4 percent positive predictive value, and 92.4 percent negative predictive value.

The same study also revealed that Bladder Care has high sensitivity for low-grade cases (88.2 percent and 97.4 percent sensitivity for bladder tumors with a Gleason score of G1 and G2, respectively) making it useful for early bladder cancer detection, Pangea noted.

"In addition to its superior sensitivity, Bladder Care is completely non-invasive," Paolo Piatti, project manager at Pangea Laboratory, said in a statement. "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."

Financial terms of the licensing agreement were not disclosed. A spokesperson for Pangea and Zymo noted that Pangea is the only laboratory that has licensed the technology, and that Zymo is open to licensing it to other laboratories and facilities.

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