SAN DIEGO & REHOVOT, Israel--(BUSINESS WIRE)--Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, today announced the publication of an analysis highlighting that Bladder EpiCheck® can reduce both patient burden and healthcare system costs in the U.S. and European countries for low grade intermediate risk non-muscle invasive bladder cancer (NMIBC). The analysis, titled “Alternating Cystoscopy with Bladder EpiCheck® in the Surveillance of Low-Grade Intermediate-Risk NMIBC: A Cost Comparison Model,” was published in the peer-reviewed journal Bladder Cancer.
This analysis was performed in an effort to better understand the economic impact of such an approach across 10 different countries with varied healthcare cost structures. Researchers developed a decision analysis model to compare standard surveillance with a modified surveillance that alternated between standard methods and use of Bladder EpiCheck every three to six months. The alternating schedule saved 8-14% of the cost for the system in 70% of the countries and resulted in a negligible cost increase in the other countries.
“Bladder cancer is the fifth most common cancer across the world, yet surveilling its recurrence remains one of the most invasive, intensive and costly processes across the oncology landscape. This includes cystoscopy: a painful procedure patients must undergo every few months,” said Aharona Shuali, M.D., vice president of medical at Nucleix. “The findings of this analysis show that Bladder EpiCheck can be used to help reduce this burden to patients with a cost saving in most countries and a negligible cost increase in remaining countries.”
Authors attributed the cost-effectiveness of this alternative strategy to Bladder EpiCheck’s high specificity of 86%. This is because lower specificity often results in patients receiving additional cystoscopies, ultimately leading to higher overall costs to the healthcare system. Importantly, for such an alternating schedule to be clinically acceptable, high sensitivity for high-grade disease is key to ensure patients with a high-grade recurrence, who are at risk of disease progression, are detected promptly and treated.
“We are currently over-monitoring low-grade NMIBC patients, which creates an enormous burden on the patients and the system, however, eliminating surveillance of these patients altogether is not an option, due to the small but significant risk of progression to high-grade disease,” said Yair Lotan, M.D., Professor of Urology at University of Texas Southwestern Medical Center. “This analysis demonstrates that a robust urine marker, such as Bladder EpiCheck, can be used to reduce the frequency and burden of cystoscopies without additional costs to the healthcare system and patients.”
About Bladder EpiCheck®
Bladder EpiCheck provides patients and clinicians with a simple, objective urine test to detect recurrence of bladder tumors. The test analyzes subtle disease-specific changes in DNA methylation markers, allowing for the detection of 92% of the high-risk (non Ta-LG) cancers. Bladder EpiCheck® demonstrated negative predictive value (NPV) of 99% for high-risk cancer, meaning that when receiving a negative Bladder EpiCheck® result, there is 99% chance that no high-risk cancer is present1. Bladder EpiCheck® is intended for use as a noninvasive method for monitoring of tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with bladder cancer. Bladder EpiCheck® is CE-marked and available in Europe. The test is not available for sale in the United States.
Nucleix is a liquid biopsy company revolutionizing cancer treatment with earlier disease detection at a time when intervention can bring the greatest impact for patients. Leveraging PCR-based epigenetics, our pioneering testing approach uses methylation-based identification for early-stage and recurring cancer detection. Our non-invasive EpiCheck® platform delivers highly accurate and sensitive results, all while providing a seamless testing option for patients and the healthcare system. We are building an EpiCheck franchise, beginning with our Bladder EpiCheck testing kit marketed in Europe for bladder cancer recurrence. We are advancing a Lung EpiCheck test toward commercialization for high-risk individuals, while advancing additional tests for high-risk diseases. For more information, please visit: https://www.nucleix.com.
1 Witjes et al. European Urology Oncology 2018;1:307–313