Pangea Laboratory has teamed up with Unilabs, a European provider of clinical lab testing and diagnostic imaging, to introduce its Bladder CARE Assay in Switzerland.
The Bladder CARE Assay is designed for a quantitative urine-based diagnosis of bladder cancer and upper tract urothelial carcinoma (UTUC). It is intended for patients with haematuria who are suspected of having either condition.
This partnership ensures the laboratory-developed test (LDT) is covered by insurance, improving patient access. It is intended to streamline non-invasive cancer diagnostics in Switzerland and expand the Bladder CARE Assay across Europe.
The collaboration will also help make Pangea Laboratory’s diagnostic solutions widely available.
Unilabs Switzerland genetics and oncology pathology head Patrick Bornand 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.”
Pangea Laboratory received the US Food and Drug Administration (FDA) breakthrough device designation for the Bladder CARE Assay in December 2023.
In 2019, the California-based diagnostics company licensed the bladder cancer test from Zymo Research.
The test analyses DNA methylation biomarkers to detect bladder cancer and upper tract urothelial carcinoma from urine samples collected at home.
The diagnostics firm said that the Bladder CARE Assay outperforms other existing commercial tests, with over 93% sensitivity, specificity, and negative predictive value for both conditions.
Pangea Laboratory chief operating officer 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.”
