Nucleix’s BE Safe @Home Project Brings Bladder Cancer Surveillance to Patients’ Homes During COVID-19 Pandemic and Beyond

Monitoring for cancer recurrence in patients with NMIBC requires patients to regularly undergo up to four invasive cystoscopies per year, which are painful procedures and require substantial resources from healthcare providers. However, outpatient procedures are currently suspended in many countries by COVID-19 regulations. This has a significant impact on patients with NMIBC due to interruption of routine follow-up schedules. Additionally, many of the patients are elderly and have an increased risk of being exposed to COVID-19; therefore, they hesitate to visit the hospital during the pandemic. Such interruption in NMIBC follow-up greatly increases the risk for undetected tumor recurrence, and for these patients, missed or avoided monitoring visits could mean the difference between early treatment and critical disease progression.

“Utilizing the Bladder EpiCheck in an at-home setting allows these patients to adhere to COVID-19 safety guidelines, as well as recommendations for ongoing surveillance to catch cancer recurrence early,” said Chris Hibberd, chief executive officer of Nucleix. “Urine samples collected at home, or at a community location nearby, can be sent to a laboratory collaborating with BE Safe @Home and then results are interpreted by their urologist. This reduces the need for in-person visits and makes Bladder EpiCheck an ideal tool to bridge the gap between follow-up cystoscopies.”

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. The test has shown high diagnostic accuracy and high performance for surveillance of disease recurrence in patients with NMIBC, proving useful as a monitoring tool to extend time between cystoscopies, which is crucial during the current pandemic.

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-grade (non Ta-LG) cancers. Bladder EpiCheck® demonstrated negative predictive value (NPV) of 99% for high-grade cancer, meaning that when receiving a negative Bladder EpiCheck® result, there is 99% chance that no high-grade 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.

About Nucleix

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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