These samples for the Bladder CARE Assay can be easily collected at home using the Pangea collection device. Credit: mi_viri / Shutterstock.

Pangea Laboratory has announced a partnership with Unilabs to introduce a non-invasive epigenetic test, the Bladder CARE Assay, in Switzerland. 

The cancer assay uses DNA methylation biomarkers to check for bladder cancer and upper tract urothelial carcinoma (UTUC) from urine samples, which can be collected in the at-home setting using the Pangea collection device.

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Through this collaboration, the companies aim to enhance cancer diagnostics in Switzerland, with plans to expand the assay’s rollout throughout Europe.

Unilabs Switzerland pathology, genetics and oncology Patrick Bornand head said: “Through this strategic partnership with Pangea Laboratory, Unilabs reinforces its commitment to driving innovation in diagnostics, bringing Bladder CARE to Switzerland as a next-generation solution that empowers early detection and advances patient care.”

The FDA previously granted breakthrough device designation for the Bladder CARE Assay. 

This assay is said to have high sensitivity, specificity, and negative predictive value (NPV) exceeding 93% for bladder cancer and UTUC, together with quantitative results.

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The results from this assay are intended to be used with existing diagnostic procedures, aiding in the initial diagnosis of bladder cancer and UTUC among patients with haematuria and suspected cases of these cancers.

Pangea Laboratory COO Dr Yap Ching Chew said: “Pangea Laboratory is committed to delivering non-invasive healthcare solutions that reduce patient burden while delivering highly accurate results. We are happy that the Unilabs team shares our vision and the belief that Bladder CARE sets a new standard in the diagnosis of bladder cancer and UTUC.”