MCM5 is a group of MCM proteins that is produced in cells during replication and is a novel cancer biomarker.
Proliferating cells express MCM5 protein at a high level, whilst quiescent terminally differentiated cells, and senescent cells lack MCM5 expression.
In contrast, both non-invasive and invasive urothelial carcinomas express MCM5 in all layers of the urothelium including superficial epithelial cells. This results in the exfoliation of MCM5-expressing tumour cells into the urine. Therefore the presence of MCM5 in the urine sediment is an excellent indicator of the presence of a urological tumour.
ADXBLADDER by Arquer Diagnostics delivers a simple, rapid and highly reliable diagnosis of bladder cancer from urine.
This ELISA kit has been designed for the detection of MCM5 protein in human urine for the diagnostic of bladder cancer in patients who have hematuria and symptoms in the lower urinary tract with suspected malignancy.
The negative predictive value of the Arquer MCM5 ELISA test is 98% (based on a prevalence of 8.38%).
Comparisons to alternative urine tests demonstrate that the Arquer's MCM5 ELISA kit has superior sensitivity to both NMP22 and urine cytology, with the MCM5 ELISA identifying all of the cases detected by these urine based methods.