A Performance Evaluation Study of Arquer’s MCM5 Elisa Test (ADXBLADDER) to Aid in the Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer

Inclusion Criteria:

Patients who have been diagnosed with NMIBC in the previous 2 years, and are attending the urology clinic for standard of care/routine monitoring cystoscopy
Patients 22 years of age or older
Patients who, in the opinion of the Investigator, are suitable for standard urological investigations as part of normal clinical practice
Patients who are, in the opinion of the Investigator, able to understand the purpose of the study and provide a full void urine specimen
Patients who are able to give voluntary, written informed consent to participate in this study

Exclusion Criteria:

Patients with known active (symptomatic) calculi within the urino-genitary system
Patients who provide less than 10mL of full void urine
Patients undergoing active treatment for interstitial cystitis
Patients currently undergoing systemic chemotherapy or systemic immunotherapy or radiotherapy. Intravesical chemotherapy or immunotherapy (BCG) is allowed
Patients who have previously been diagnosed with renal cancer, prostate cancer, Muscle Invasive Bladder cancer, an upper tract tumour, or CiS in the prostatic urethra
Patients who have had urological instrumentation to the urinary tract within 14 days prior to the test
Male patients undergoing active treatment for prostatitis