Diagnosis: Hematuria
Treatment: CxBladder Detect test
The insurer denied the CxBladder Detect test.
The health plan's determination is upheld.

The patient is a female with diagnosis of microscopic hematuria. A CxBladder test was performed to evaluate the diagnosis. This is under review.

The CxBladder Detect test is not likely to be more beneficial than any standard treatment or treatments for the insured's life threatening or disabling condition or disease.

CxBladder is a novel multiplex mRNA (messenger ribonucleic acid) assay(uRNA) for the diagnosis and stratification of urothelial cancer. It uses polymerase chain reaction amplification to quantify 4 mRNAs from unfractionated urine. Only one study has evaluated the efficacy of this test in patients with gross hematuria. The study was done in Australasia and was funded by the manufacturer of the test. Until larger randomized studies are published, CxBladder is not indicated for diagnosis or management of bladder cancer.

In addition, AUA Guidelines on microhematuria do not recommend use of urine cytology and urine markers as a part of the routine evaluation of patients with asymptomatic microscopic hematuria. The guidelines state, "Clinicians should not use urine cytology or urine-based tumor markers in the initial evaluation of patients with microhematuria.