Biomarker testing

Author: Rugvedita Parakh, M.D. (see Authors page)

Revised: 21 March 2016, last major update February 2013

Copyright: (c) 2003-2016,, Inc.

PubMed Search: Bladder biomarkers[title]
Table of Contents
Definition / General
Cite this page: Biomarker testing. website. Accessed October 24th, 2016.
Definition / General

Bladder Tumor Antigen (BTA) test
  • BTA Stat: done at physician's office or home
  • BTA Trak: done by reference laboratory; a quantitative sandwich assay
  • Based on the detection of the human complement factor H-related protein
  • Only indicated in patients with prior history of urothelial carcinoma
  • Sensitivity up to 50% for low grade urothelial carcinomas, which is higher than cytology (Can Urol Assoc J 2008;2:212)
  • Sensitivity of 69% for BTA Trak test
  • The main problem with BTA is relatively high false positive rate

Nuclear Matrix Protein 22
  • Part of the structural framework of the nucleus
  • Involved in DNA replication, ribonucleic acid transcription and regulation of gene expression
  • Nuclear mitotic apparatus proteins (NMP22) have a concentration in urothelial carcinomas of 25x normal urothelial cells
  • Either an office based test or a reference laboratory test (BladderChek®, Matritech)
  • Used to detect new cancers and to follow-up patients with a prior history of urothelial carcinoma
  • Reported sensitivity of 34.6%–100% for NMP22 Bladder Cancer Test and 49.5%–65.0% for BladderChek assays

Bladder Cancer Immunofluorescence Assay (former Immunocyt®)
  • An immunofluorescence assay
  • A cocktail of 3 monoclonal antibodies; M344, LDQ10 and 19A211
  • M344 and LDQ10 detect a mucin-like antigen
  • 19A211 recognizes a high molecular weight glycosylated form of carcinoembryonic antigen in exfoliated tumor cells
  • The test requires the correlation of the immumunofluorescence results with cytology
  • The overall sensitivity of the combined Bladder Cancer Immunofluorescence Assay and cytology assay is approximately 84%

  • Fluorescent in situ hybridization (FISH) probe set
  • A mixture of 4 fluorescent labeled DNA probes; a locus specific probe to the 9p21 band on chromosome 9 and to the centromere of chromosomes 3, 7 and 17
  • The individual sensitivity of the centromeric probes is 73.7% for chromosome 3, 76.2% for chromosome 7, 61.9% for chromosome 17
  • The sensitivity of homozygous 9p21 deletion for urothelial carcinoma is 28.6%
  • The UroVysion® test: 72% sensitivity and 83% specificity
  • According to stage of the disease, for pTa tumors sensitivity ranges from 65 to 73% and for pT1-T4 urothelial carcinomas 95-100%
  • UroVysion® and cytology have similar specificity but superior specificity to BTA
  • Patients with a positive UroVysion® test result, equivocal (atypical or suspicious) cytology diagnosis and negative cystoscopy have a higher incidence of urothelial carcinoma on subsequent follow-up
  • The UroVysion® test seems to have limited value due to a higher incidence of false positives and false negatives
  • The positive predictive value of UroVysion® for bladder carcinoma is 65% in patients with a 40+ pack year history of smoking, but only 20% in nonsmokers