REHOVOT, Israel—Nucleix Ltd. announced today that Bladder EpiCheck, its biomarker-based non-invasive urine test for the detection of non‐muscle invasive bladder cancer (NMIBC), was shown to be an effective rule-out test for NMIBC recurrence, thereby minimizing the need for invasive cystoscopies. The analysis, spearheaded by Prof. Shahrokh F. Shariat, head of the Urology department in Vienna, adjunct professor in Weil Cornel, NY and UT Southwestern, TX, was recently published in BJU International.
“NMIBC is a highly recurrent disease that requires a long term follow-up. Due to the limited predictive accuracy of risk assessment capabilities today, the follow-up regime relies on the patient’s history, and current guidelines suggest standardized follow-up of patients with NMIBC,” explained Shariat. “Different biomarkers have been offered for NMIBC monitoring via non‐invasive urine‐based molecular tests, but none of them reached sufficient diagnostic accuracy to become standard-of-care.”
“Our analysis demonstrated that adding Bladder EpiCheck to patient information significantly improves the accuracy of predicting the presence of high-grade cancer from 72.7% to 94.9%. Such high predictive accuracy allows physicians to use Bladder EpiCheck as a rule-out test, to properly select high-risk patients for invasive cystoscopy and reduce 80% of cystoscopies without missing a single high-grade cancer,” Shariat continued.
Bladder EpiCheck is a CE-approved urine test for monitoring bladder cancer that was clinically validated in several independent cohorts in leading hospitals and labs throughout Europe. Bladder EpiCheck has shown in clinical trials best performance of a non-invasive tool in detection of bladder cancer recurrence when compared to the invasive standard-of-care. The test demonstrated a high negative predictive value (NPV) of 99%, indicating that if the test is negative, there is a 99% chance that the patient does not have a dangerous tumor. This is coupled with a low rate of false positive results (specificity of 88%).
Shariat and his team performed an independent analysis of the data from the recent Bladder EpiCheck Phase 3 study led by Prof. Fred Witjes, Radboud UMC in Nijmegen, in order to assess the performance of Bladder EpiCheck and its impact on clinical decision making. A total of 357 patients were included in the analyses, which confirmed the high diagnostic accuracy and performance of the Bladder EpiCheck test. The negative predictive value (NPV) of 99.3% for high grade cancers was the same as that obtained in the previous analysis.
“In accordance with the first report of the trial, we found that Bladder EpiCheck could exclude the presence of high‐grade BCa [bladder cancer] with an NPV of 99.3%, that is a false‐negative result of 0.7 per 100 patients with negative results. This provides physicians and patients with a very high certainty that no tumour recurrence is present if the test is negative, largely outperforming the currently available urinary‐based biomarkers and cystoscopy,” the article notes. “For example, in recent studies evaluating blue‐light cystoscopy in the surveillance setting, the sensitivity and specificity of white‐light cystoscopy were 79.3% and 78%, respectively. Moreover, the overall sensitivity and specificity for urine‐based biomarkers, such as NMP22, reached only 73% and 80%, respectively […] Bladder EpiCheck achieved a sensitivity of 89% and a specificity of 88% for high‐grade BCa.”
“[T]he Bladder EpiCheck demonstrated a robust performance and significant impact on clinical decision‐making and, based on current data, could therefore be implemented in clinical practice to decide whether to perform a cystoscopy or not. For example, given a personal threshold probability of 15% (i.e. a patient would undergo a cystoscopy if the probability of cancer was >15%), every decision based on Bladder EpiCheck would avoid 49.5% of unnecessary cystoscopies without missing any cancer,” continues the article.
“We are very pleased with the results of the analysis published in BJU International,” said Opher Shapira, Ph.D., CEO of Nucleix. “We strive to develop meaningful tools that can make a real impact on the practice of medicine and on patients. These findings demonstrate how using Bladder EpiCheck for personalized medicine can improves patients’ lives while alleviating the economic burden of bladder cancer.”