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Biomarker testing

Reviewer: Rugvedita Parakh, M.D. (see Reviewers page)
Revised: 9 February 2013, last major update May 2010
Copyright: (c) 2003-2013, PathologyOutlines.com, Inc.

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

End of Bladder > Cytology > Biomarker testing

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