KRT17

Patients with pancreatic cancer who received chemotherapy both before and after surgery experienced longer survival rates than would be expected from surgery followed by chemotherapy, according to a new study. Patients with pancreatic cancer who received chemotherapy both before and after surgery experienced longer survival rates than would be expected from surgery followed by chemotherapy, according to a new study from researchers at Yale Cancer Center (YCC) and Yale School of Medicine. The study, published June 20 in JAMA Oncology, included patients with pancreatic ductal adenocarcinoma (PDAC), which accounts for 90% of pancreatic cancers. An aggressive cancer with a high mortality rate, PDAC is predicted to become the second leading cause of cancer-related deaths in the U.S. by 2030. The findings, say the researchers, are encouraging for the 15 to 20% of pancreatic cancer patients whose tumors are operable. The single-arm (only one treatment type or regimen) Phase II trial evaluated a modified form of the chemotherapy treatment FOLFIRINOX (a combination treatment consisting of leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin approved in 2011 as a first-line treatment for patients with metastatic pancreatic cancer). Patients in the trial received six cycles of the modified FOLFIRINOX before surgery, followed by an additional six cycles of the chemotherapy treatment after surgery. The modified regimen consisted of slightly lower doses of FOLFIRINOX to improve tolerability, which was previously shown in a 2016 publication not to impact outcomes negatively. Of the 46 patients who started the modified treatment, 37 completed all six cycles of chemotherapy before surgery and 27 had successful tumor removal operations. For all enrolled patients, the 12-month progression-free survival rate -- meaning the disease did not worsen -- was 67%, indicating significant progress in controlling the disease. Furthermore, 59% of all patients lived at least two years after completing the full chemotherapy treatment plan and surgery. The study was the first of its kind for patients with PDAC when senior author and YCC member Dr. Jill Lacy started it in 2014. The study goal had been a 12-month progression-free survival rate of at least 50% of patients. "When the study launched, even with operable pancreatic cancers, 90% of patients were still relapsing and dying from their cancer eventually," said Dr. Michael Cecchini, the first author of the study and the co-director of the colorectal program at the Center for Gastrointestinal Cancers at Smilow Cancer Hospital and YCC. "We sought to move chemotherapy up in their treatment regimen and give it before surgery to see if we could improve the outcome for our patients." The study used advanced techniques to monitor the progress of treatment, including analyzing circulating tumor DNA (ctDNA) and using the cancer biomarker keratin 17 to help predict outcomes. For example, patients with detectable ctDNA four weeks post-surgery had significantly worse progression-free survival than those who had no detectable ctDNA. Cecchini said larger randomized clinical trials are needed to continue to investigate the role of FOLFIRINOX before surgery for patients with operable PDAC. "I think even though there have been changes in standard of care for patients with this aggressive pancreatic cancer type, we have here very promising data to justify a larger study," said Cecchini.

SAN JOSE, Calif., Oct. 5, 2023 /PRNewswire/ -- KDx Diagnostics Inc., a leading innovator in non-invasive bladder cancer tests, is pleased to announce the issuance of important patents in the US, EU, and South Korea relating to their joint work in developing new tests to aid in the treatment of bladder cancer. The issued patents cover technologies for analyzing Keratin 17 in urine to detect the presence or absence of bladder cancer. The patents reward the innovations of the joint team of scientists and researchers who developed the technology. "These new patents complement our ongoing commercial efforts to provide non-invasive technologies for bladder cancer detection and demonstrate we've made groundbreaking advances," said Nam W. Kim, PhD, CEO and CTO at KDx, and coinventor of the patents. "We are focused on delivering cutting-edge solutions that address the needs of our customers and drive industry growth." "As predicted by our research, Keratin 17 is an important marker for the detection of bladder cancer in patients," said Kenneth R. Shroyer, MD, PhD, The Marvin Kuschner Professor and Chair, Department of Pathology, Renaissance School of Medicine, Stony Brook Cancer Center, and coinventor of the patents. "We believe that the application of Keratin 17 in clinics will provide significant benefits to patients by providing a more accurate assessment of bladder cancer patients." About KDx Diagnostics Inc. Founded in 2017, KDx is 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. URO17® is a research use only product and is currently available as Laboratory Developed Test in the U.S. Contact: Public Relations KDx Diagnostics Inc. 408-628-7715 [email protected] URO17 is a registered trademark of KDx. SOURCE KDx Diagnostics Inc.

NEW HAVEN, Conn. and CAMPBELL, Calif., June 4, 2021 /PRNewswire/ -- 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 relapse. The study was published online today in 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 URO17® 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. CONTACT: info@kdxdiagnostics.com