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Arquer secures approval for cancer diagnostic study
March 2016
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SUNDERLAND, U.K.—Arquer Diagnostics Ltd. recently received ethical approval for a six-month clinical study of its Mcm5-ELISA test for the diagnosis of bladder cancer from a Health Research Authority Research Ethics Committee. The current diagnostic standard is cystoscopy, but the Mcm5-ELISA is a non-invasive urine test that detects the presence of minichromosome maintenance complex component 5 (Mcm5) protein, which are shed into urine by both prostate and bladder tumors and regarded as excellent biomarkers. A previous trial in patients with hematuria (blood in the urine) showed Mcm5-ELISA test has a sensitivity of 83 percent, specificity of 77 percent and negative predictive value of 98 percent. The new study will begin early this year, involving 800 patients with hematuria, with the results of the Mcm5 test compared with outcomes of routine investigations, specifically if the hematuria was caused by bladder cancer.

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