SAN DIEGO & REHOVOT, ISRAELL – (COMMERCIAL THREAD) – Nucleix, a liquid biopsy company that is revolutionizing cancer treatment by detecting disease earlier, today announced data from two abstracts showcasing its Bladder EpiCheckÂ® test at the 36th Annual Virtual Congress of the European Association urology (UAE).
The first abstract, titled “Real evidence of the alternation of cystoscopy / cytology with the EpiCheck bladder in NMIBC surveillance”, shows the results of a pilot project carried out at Radboud University Medical Center evaluating the feasibility and clinical results of the alternation between cystoscopy / cytology and EpiCheck bladder in the surveillance of non-muscle invasive bladder cancer (NMIBC). To alleviate the burden of invasive and expensive standard monitoring methods on patients, urine collection was performed at home and shipped to a central laboratory to perform the Bladder EpiCheck test. In the pilot analysis, the patients followed showed that Bladder EpiCheck achieved a sensitivity of 100% for high-grade diseases, with a specificity of 88%, thus avoiding 76% of unnecessary cystoscopies. The authors concluded that this modified surveillance schedule was both safe and cost effective due to the high sensitivity of Bladder EpiCheck for high grade diseases and its high specificity.
âThis is the first published evidence of the use of an alternate urine marker program, such as Bladder EpiCheck, and cystoscopy or cytology. Due to Bladder EpiCheck’s high sensitivity for high grade diseases and high specificity, and a well-planned infrastructure, all high grade tumors, including muscle invasive tumors, were detected while avoiding 76 % of unnecessary cystoscopies, âsaid Fred Witjes, MD Professor of Medical Sciences at Radboud University Medical Center. âAs a result of the pilot project, Radboud University Hospital implemented this monitoring program as a routine for all NMIBC patients. ”
The second abstract entitled “Urinary DNA methylation biomarker test (EpiCheckÂ® test) in the diagnosis of urothelial carcinoma of the upper tract: results of a prospective single-center study”, evaluated the performance of Bladder EpiCheck in the detection of urothelial carcinoma of the upper urinary tract. (UTUC) in 80 consecutive patients undergoing ureteroscopy for the diagnosis, treatment or follow-up of UTUC. The study found that Bladder EpiCheck achieved a high sensitivity of 95.8%; a high-grade negative predictive value of 97.2%; and a specificity of 80.6% in urine collected at the ureter-bladder junction, compared to 80.0%, 90.0% and 91.7% for cytology, respectively.
âIt is very difficult to stage an UTUC with a biopsy, because we know that up to 30% of UTUCs are underestimated with this technique. This can be detrimental to the patient because high grade UTUC, if missed, can progress to metastasis very quickly. Alternatively, if a patient with a low grade tumor is mistaken for a high grade, or if high grade disease cannot be ruled out, he may undergo unnecessary procedures such as removal of the ureter and kidney from this. side, âsaid Dr Alberto Breda, Head of the Urology Oncology Unit and Kidney Transplant Team at FundaciÃ³ Puigvert, Barcelona, ââSpain. “The results of this study show that Bladder EpiCheck may be a useful tool in the context of UTUC and could play a crucial role in the diagnosis and monitoring of disease, particularly in the elimination of high disease. grade.”
About the EpiCheckÂ® bladder
Bladder EpiCheck provides patients and clinicians with a simple and objective urine test to detect recurrence of bladder tumors. The test analyzes subtle disease-specific changes in DNA methylation markers, allowing detection of 92% of high-risk (non-Ta-LG) cancers. Bladder EpiCheckÂ® has demonstrated a negative predictive value (NPV) of 99% for high risk cancer, which means that upon receiving a negative Bladder EpiCheckÂ® result, there is a 99% chance that no cancer at high risk is present1. Bladder EpiCheckÂ® is intended for use as a non-invasive method of monitoring tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with bladder cancer. The EpiCheckÂ® bladder is CE marked and available in Europe. The test is not available for sale in the United States.
Nucleix is ââa liquid biopsy company that is revolutionizing cancer treatment with earlier detection of disease at a time when intervention can have the greatest impact for patients. Taking advantage of PCR-based epigenetics, our pioneering testing approach uses methylation-based identification for early and recurrent cancer detection. Our non-invasive EpiCheckÂ® platform provides highly accurate and sensitive results, while providing a transparent testing option for patients and the healthcare system. We are building an EpiCheck franchise, starting with our Bladder EpiCheck test kit marketed in Europe for bladder cancer recurrence. We are advancing a Lung EpiCheck test towards 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