A revolutionary new urine screening test that uses a novel Keratin 17 (K17) cancer biomarker can detect the presence of new bladder cancer in patients with hematuria, or blood in the urine, according to a study led by researchers at Yale Cancer Center, Stony Brook University, and KDx Diagnostics, Inc. The findings also show the test can detect recurrent bladder cancer in patients under surveillance for relapse.

The study was published online June 4 in the American Journal of Clinical Pathology. According to the American Cancer Society, an estimated 81,000 cases of bladder cancer will be diagnosed in the United States this year. However, accurate detection of bladder cancer, or urothelial carcinoma (UC), is often difficult and expensive, requiring invasive camera-based testing methodology.

“Current methods used in cytology labs are based on subjective microscopic features that may not reliably distinguish between benign cells and low-grade urothelial carcinomas”, said Luisa Escobar-Hoyos, assistant professor of therapeutic radiology at Yale Cancer Center and co-lead author of the study. “There was an unmet clinical need to find biomarkers to improve diagnostic accuracy for UC. Following up on prior studies from our lab, this research confirms that K17 is a highly sensitive diagnostic test for initial screening and detection of recurrent cancer across all grades of UC”, he added.

The study was defined by two matched cohorts: a discovery cohort in which the optimal number of positive cells for optimal sensitivity and specificity was identified, and a validation cohort in which a new set of patients was evaluated. In this validation cohort, the sensitivity and specificity in patients were 86% and 92%, respectively. When the patients were divided into hematuria and recurrent bladder cancer populations, the data showed sensitivity and specificity of 100% and 83%, respectively, in patients with hematuria, and sensitivity and specificity of 92% and 100%, respectively, in patients with recurrent bladder cancer.

“We are pleased to report that the test using a K17 biomarker continues to show high sensitivity in identifying both new cancers from hematuria patients and recurrent cancer from patients being monitored for UC”, said Nam W. Kim, PhD, chief executive officer and chief technology officer of KDx Diagnostics, Inc. “There is now a growing body of evidence that the non-invasive, K17 urine test will make a significant positive impact on detection and management of UC” he stated.