The partnership between Stanford Medicine researchers and VA Palo Alto Health Care System developed a non-invasive urine test for the diagnosis of bladder cancer, as well as to support the selection of more effective treatment options. They highlighted that around 85,000 people in the U.S. each year are diagnosed with bladder cancer, which represents the sixth largest cancer type and is prone to recurrences. They also stated that the current diagnostic and surveillance method utilized cystoscopy, which can miss approximately 30% of cancers.
This test helps in the detection of uRARE-seq, which measures RNA fragments shed by tumour cells into urine. This further helps in revealing genes actively used by cancer cells, predicting their behaviour along with their presence. Moreover, these results were published on October 2, 2026, in 'Nature Medicine'. Additionally, senior author Dr Maximilian Diehn, professor of radiation oncology at Stanford, stated that "Measuring tumour DNA in urine can tell us whether a cancer is present". He also added that "Analysing RNA can tell us not only whether a cancer is present, but also what it's doing".
The new urine test developed by Stanford Medicine researchers offers a non-invasive approach and promotes the selection of appropriate treatment options for bladder cancer, attracting healthcare professionals. The test identified 95% of people with localised bladder cancer and correctly gave a negative result to 90% of those without the disease among 683 urine samples from patients and healthy volunteers. The test thus enables earlier detection of recurrence and supports more personalised treatment decisions.
The test also helps differentiate low-grade from high-grade bladder cancer, residual disease after surgery, and after BCG immunotherapy. BCG immunotherapy refers to a treatment in which a weakened tuberculosis vaccine bacterium is placed directly into the bladder in order to stimulate an immune attack on remaining cancer cells. The study also recorded that the patient who later responded to BCG had pre-treatment urine RNA signals which were enriched for genes linked to T-cell and immune-signalling activity. Additionally, signs of rapidly dividing tumour cells were detected in the patients who did not respond to the treatment. This added another major benefit of the test, which contributed to the detection of the recurrence of bladder cancer after someone has been treated for the disease.
Therefore, considering these factors, a new biomarker was developed by the researchers, which offers high accuracy in predicting whether a tumour was more likely to respond to immunotherapy or chemotherapy, supporting clinicians in reserving BCG for patients with the most benefit. Furthermore, the senior author, Dr Joseph Liao, chair of urology at Stanford, highlighted that "There are currently no biomarkers at all that are recommended or approved for surveillance," and "If we can guide those choices, we have the potential to help both patients and clinicians".
Based on the application of the new bladder cancer detection test, the researchers plan to validate uRARE-seq in larger, prospective, multi-centre trials before introducing the product to the market for standard diagnosis, surveillance or treatment selection.
Researchers from Resero Bio, which is a diagnostic company focused on developing a next-generation liquid biopsy platform, and a Stanford spinout formed to commercialise the technology, and VA Palo Alto Health Care System, one of the leading veterans' medical networks, providing comprehensive inpatient, outpatient, and specialty care across multiple, played a key role in this study. Dr Maximilian Diehn contributed to the senior authorship with Ash Alizadeh, who is an MD, PhD, and associate professor of medicine, while postdoctoral scholars, namely, Jonathan Dudley, MD, and Joseph Schroers-Martin, MD, were the lead authors of the study. Furthermore, the university also disclosed that numerous authors have ownership interests in Resero Bio or patents related to urine cell-free RNA analysis.
With the growing incidence of cancer globally, the demand for their early and accurate detection is rapidly increasing. Additionally, growing health awareness is also driving the demand for effective treatment options. This creates an opportunity for the new non-invasive urine test developed by Stanford Medicine researchers for the detection of bladder cancer. Furthermore, its benefits, such as early cancer detection, selection of appropriate treatment options, differentiation of low-grade from high-grade bladder cancer, and detection of recurrent bladder cancer, also encourage its use. Additionally, their approach is likely to open new market opportunities and intensify market competition.
