Revolutionary New Urine Screening Test Using New Keratin Cancer Biomarker 17 (K17) May Detect New Bladder Cancer In Patients With Hematuria Or Blood In The Urine, Study Finds conducted by researchers at Yale Cancer Center, Stony Brook University and KDx Diagnostics, Inc. The results also show that the test can detect recurrent bladder cancer in patients being watched for relapse. The study was published online today 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. 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 laboratories are based on subjective microscopic features which may not reliably distinguish between benign cells and low grade urothelial carcinomas,” said Luisa Escobar-Hoyos, MSc, PhD, assistant professor of therapeutic radiology at the Yale Cancer Center and co-lead author of the study. âThere was an unmet clinical need to find biomarkers to improve the diagnostic accuracy of UC. Building on previous studies in our laboratory, this research confirms that K17 is a very sensitive diagnostic test for the initial screening and detection of recurrent cancer in all stages of UC.
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, sensitivity and specificity in patients were 86% and 92%, respectively. When patients were divided into populations of hematuria and recurrent bladder cancer, the data showed sensitivity and specificity of 100% and 83%, respectively, in patients with hematuria, and sensitivity and specificity. 92% and 100%, respectively, in patients with recurrence. bladder cancer.
“We are pleased to report that the assay using a K17 biomarker continues to show high sensitivity in identifying both new cancers in patients with hematuria and recurrent cancers in patients monitored for UC,” said Nam W. Kim, PhD, Managing Director and CEO. Chief Technology Officer of KDx Diagnostics, Inc. âThere is now growing evidence that the K17 non-invasive urine test will have a significant positive impact on the detection and management of UC. “