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Data Includes First Real World Evidence on Alternating Bladder EpiCheck® and Cystoscopy for Surveillance of Non-Muscle Invasive Bladder Cancer (NMIBC)
SAN DIEGO & REHOVOT, ISRAEL--(BUSINESS WIRE)-- Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, today announced data from two abstracts featuring its Bladder EpiCheck® test at the 36th Annual European Association of Urology (EAU) Virtual Congress.
The first abstract titled, "Real world evidence of alternating cystoscopy/cytology with Bladder EpiCheck in NMIBC surveillance," shows the results of a pilot performed at Radboud University Medical Center evaluating the feasibility and clinical outcomes of alternating between cystoscopy/cytology and Bladder EpiCheck in non-muscle invasive bladder cancer (NMIBC) surveillance. To alleviate the burden of invasive and costly standard surveillance methods on patients, urine collection was performed at home and shipped to a central lab to perform the Bladder EpiCheck test. In the pilot analysis, patients with follow-up showed Bladder EpiCheck achieved 100% sensitivity for high-grade disease, with specificity of 88%, thereby avoiding 76% of unnecessary cystoscopies. Authors concluded this modified surveillance schedule was both safe and cost-effective due to Bladder EpiCheck's high sensitivity for high-grade disease and high specificity.
"This is the first published evidence for using an alternating schedule of a urine marker, such as Bladder EpiCheck, and cystoscopy or cytology. Due to Bladder EpiCheck's high sensitivity for high-grade disease and high specificity, and a well-planned infrastructure, all high-grade tumors, including muscle invasive tumors, were detected while avoiding 76% of unnecessary cystoscopies," said Fred Witjes, M.D., Professor of Medical Sciences at Radboud University Medical Center. "As a result of the pilot, Radboud University hospital has implemented this monitoring schedule as a routine for all NMIBC patients."
The second abstract titled, "DNA methylation urine biomarkers test (EpiCheck® assay) in the diagnosis of upper tract urothelial carcinoma: results from a single-center prospective study," evaluated the performance of Bladder EpiCheck in the detection of upper urinary tract urothelial carcinoma (UTUC) among 80 consecutive patients undergoing ureteroscopy for the diagnosis, treatment or follow-up of UTUC. The study found that Bladder EpiCheck achieved a high-grade sensitivity of 95.8%; a high-grade negative predictive value of 97.2%; and a specificity of 80.6% in urine collected from the ureter-bladder junction, compared to 80.0%, 90.0% and 91.7% for cytology, respectively.
"It is very challenging to stage a UTUC with a biopsy, as we know that up to 30% of UTUC are understaged with this technique. This can be detrimental to the patient as high-grade UTUC, if missed, can progress to metastases very quickly. Alternatively, if a patient with a low-grade tumor is mistaken for high-grade, or high-grade disease can't be ruled-out, they might undergo unnecessary procedures such as removal of the ureter and kidney of that side," said Dr. Alberto Breda, head of the oncological urology unit and the kidney transplant team in Fundació Puigvert, Barcelona, Spain. "The results of this study show that Bladder EpiCheck can be a useful tool in the UTUC setting and could play a crucial role in the diagnosis and follow-up of the disease, particularly in ruling-out high-grade disease."
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
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