Newswise — A study led by researchers at Yale Cancer Center, Stony Brook University and KDx Diagnostics, Inc., examined a revolutionary new urine screening test that utilizes a novel Keratin 17 (K17) cancer biomarker, and revealed the test can detect the presence of new bladder cancer in patients with hematuria, or blood in the urine. The findings also show the test can detect recurrent bladder cancer in patients under surveillance for recurrence. 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 labs are based on subjective microscopic features that may not reliably distinguish between benign cells and low-grade urothelial carcinomas,” said Luisa Escobar-Hoyos, MSc, PhD, 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.”

The study was defined by two matched cohorts- a discovery cohort where the optimal number of positive cells for optimal sensitivity and specificity was identified, and a validation cohort where 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% 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.”

About Yale Cancer Center Yale Cancer Center (YCC) is one of only 51 National Cancer Institute-designated comprehensive cancer centers in the nation and the only such center in Connecticut. Cancer treatment for patients is available at Smilow Cancer Hospital through 13 multidisciplinary teams and at 15 Smilow Cancer Hospital Care Centers in Connecticut and Rhode Island. Comprehensive cancer centers play a vital role in the advancement of the NCI’s goal of reducing morbidity and mortality from cancer through scientific research, cancer prevention, and innovative cancer treatment.

About KDx Diagnostics, Inc. Founded in 2017, KDx is focused on developing non-invasive cancer tests to improve early detection and therapy decisions in cancer. The URO17® bladder cancer test developed by KDx may prove to be the most sensitive and specific for bladder cancer developed to date. KDx plans to develop tests based on the same biomarker for other platforms and sample types and expand its product line into other cancer diagnostic tests.  The URO17® bladder cancer test is for Research Use Only in the US.


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