Therapy Areas: Respiratory
Nucleix Expands EU Label Indication of Bladder EpiCheck to Include the Detection of Primary Bladder Cancer and Detection of Primary and Recurrent Upper Tract Urinary Cancer
22 June 2022 - - US-based liquid biopsy company Nucleix has expanded the European Union label indication of its Bladder EpiCheck test, the company said.

Bladder EpiCheck detects DNA methylation patterns in urine that are associated with urothelial cancer.

The technology was initially indicated for use as a non-invasive method for the monitoring of tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with bladder cancer.

The current update expands the label indication to also include aiding in the detection of primary bladder cancer and upper tract urothelial carcinoma in patients presenting with hematuria and/or other urinary tract symptoms and/or findings with a suspicion of malignancy, and the detection of recurrent UTUC, in conjunction with standard diagnostic procedures.

Bladder EpiCheck provides patients and clinicians with a simple, objective urine test to detect primary and recurrent bladder and upper urinary tract cancers.

The test analyzes subtle disease-specific changes in DNA methylation markers, with sensitivity of 91-96% of high-grade cancers.

Bladder EpiCheck demonstrated negative predictive value 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 present.

Overall specificity of Bladder EpiCheck is 84%, 81% and 98% for recurrent bladder cancer, UTUC and primary cancers, respectively, ensuring a low rate of false positive results.

Bladder EpiCheck is intended for use as a non-invasive method for detection of urinary tract cancers in conjunction with standard methods.

Bladder EpiCheck is CE-marked and commercially available in Europe. The test is not available for sale in the United States.

Nucleix is a liquid biopsy company advancing cancer treatment with earlier disease detection at a time when intervention can bring the greatest impact for patients.

Leveraging NGS and PCR-based epigenetics, the company's pioneering testing approach uses methylation-based identification for early-stage and recurring cancer detection.

The company's non-invasive EpiCheck platform delivers highly accurate and sensitive results, all while providing a seamless testing option for patients and the healthcare system.

The company is building an EpiCheck franchise, beginning with the Bladder EpiCheck testing kit, marketed in Europe for the detection of primary and recurrent bladder cancer and Upper Tract Urinary Cancer.

The company is advancing a Lung EpiCheck test toward commercialization for high-risk individuals, while advancing additional tests for high-risk diseases.