Pangea Laboratory and Unilabs have announced a strategic collaboration to introduce the Bladder CARE Assay, an advanced non-invasive diagnostic tool for early detection of bladder cancer and Upper Tract Urothelial Carcinoma (UTUC), in Switzerland. This partnership represents a transformative step in oncological diagnostics within the region, offering a more patient-centric and effective solution compared to conventional approaches. The collaboration aims to enhance accessibility to early detection methods and reduce the invasiveness of traditional diagnostic techniques for bladder-related cancers.

A Revolutionary Step in Bladder Cancer Detection

The Bladder CARE Assay is a highly sensitive, non-invasive urine test designed to detect bladder cancer and UTUC using advanced DNA methylation analysis. Unlike traditional diagnostic tools, such as cystoscopy, which are often invasive and uncomfortable, Bladder CARE enables patients to collect urine samples from the comfort of their homes. This flexibility not only ensures higher patient compliance but also provides a cost-effective alternative for routine monitoring and early detection of bladder malignancies. Clinical studies demonstrate that Bladder CARE has a sensitivity of 93.5% and a specificity of 92.6%, making it one of the most reliable tests currently available for the detection of these cancers.

According to Pangea Laboratory, Bladder CARE measures the methylation levels of three bladder cancer-specific DNA biomarkers, allowing clinicians to effectively identify the presence of malignancy in the early stages. The test’s proprietary algorithm, developed by Pangea, calculates results as values on the Bladder CARE Index (BCI), which indicates the probability of bladder cancer presence. Patients with a BCI below 2.5 are classified as “negative,” while those above 10.0 fall into the “positive” category. This quantitative nature of the assay, as highlighted by Dr. Siamak Daneshmand from the USC Institute of Urology, is what sets it apart from other available tests—offering not only detection but also insights into treatment responses and the progression of bladder cancer.

Why the Partnership Matters

The strategic partnership between Pangea Laboratory and Unilabs is geared towards expanding the reach of Bladder CARE across Switzerland and potentially into other parts of Europe. Unilabs, one of the leading diagnostic services providers in Europe, brings its established healthcare infrastructure and expertise in clinical diagnostics, which will help in streamlining the rollout of the Bladder CARE Assay. This collaboration is expected to strengthen the delivery of advanced, patient-centric diagnostic solutions in Switzerland, contributing to the improved detection rates of urothelial cancers in the country.

Larry Jia, MD, founder and CEO of Pangea, noted that the partnership with Unilabs will enable faster adoption of this cutting-edge diagnostic tool. The launch of Bladder CARE in Switzerland aims not only to help detect bladder cancers earlier but also to reduce the burden on healthcare systems by potentially minimising the need for invasive procedures. “The FDA’s recognition of Bladder CARE validates its potential to reshape cancer diagnostics,” he said, referencing the test’s recent Breakthrough Therapy Designation, which will accelerate its development and regulatory review across other regions.

Patient-Friendly and Effective Testing

One of the key differentiators of the Bladder CARE Assay is its patient-centric approach. Bladder cancer surveillance typically involves frequent cystoscopies, which are not only uncomfortable but also costly. The Bladder CARE Assay eliminates many of these challenges, providing patients with a urine collection kit that can be used at home—with no dietary or medication restrictions required. Once collected, the urine samples are stabilised using a special reagent and can be shipped to the laboratory for analysis. Results are usually delivered within 3 to 7 days to the clinician, enabling swift follow-up actions if necessary.

Additionally, the low limit of detection (LOD) of Bladder CARE—able to identify cancer cells present at just 0.046% concentration—plays a critical role in ensuring early diagnosis. This feature is particularly advantageous for monitoring patients post-treatment, as it allows for early detection of recurrence and helps doctors make more informed decisions about subsequent treatment options.

Expert Opinions and Clinical Implications

An expert in urology explained that the epigenetic basis of the Bladder CARE test, which measures methylation levels of specific DNA markers, is a significant leap in early cancer detection. They believe this approach could eventually become a standard component of cancer screening and post-treatment surveillance, due to its non-invasive nature and high accuracy. The quantitative nature of the Bladder CARE Assay offers valuable insights into patient treatment responses, which could particularly benefit patients undergoing neoadjuvant chemotherapy for muscle-invasive bladder cancers.

The assay has also proven effective for Upper Tract Urothelial Carcinoma, with studies showing a sensitivity rate of 96.0% for UTUC cases. These impressive results reinforce Bladder CARE’s role as a reliable screening tool that can support clinicians in making accurate and timely decisions, ultimately improving patient outcomes.

Future Outlook for Bladder CARE in Switzerland

With the formal launch of Bladder CARE in Switzerland, Pangea and Unilabs hope to bring about a substantial transformation in how bladder cancers are diagnosed and managed. As the two companies work together to further validate and promote this innovative test, the focus remains on improving the quality of life for cancer patients through early detection and minimally invasive techniques. Multicentre clinical trials are already being planned to validate Bladder CARE’s utility in a wider patient population, potentially paving the way for broader European adoption.

Pangea Laboratory’s vision for the future of cancer diagnostics aligns well with Unilabs’ commitment to making healthcare more accessible and effective. By bringing cutting-edge technologies like Bladder CARE to mainstream diagnostics, the partnership aims to set a new standard for cancer detection and patient care across Europe.

  bladder cancer, Bladder CARE, Larry Jia, Pangea, Pangea Laboratory, Siamak Daneshmand, Switzerland, Unilabs, Upper Tract Urothelial Carcinoma, USC Institute of Urology