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The hTERT­ adjunct ICC test provides more clinical detail to resolve atypical cytology results. 

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1 in 4  
Cytology cases result in atypical/equivocal or inconclusive results. 

Atypical results have historically been challenging for urologists

  • Cytology is effective at diagnosing high-grade urothelial carcinoma (HGUC)
  • However, ~1 in 4 cases result in atypical/equivocal, and inconclusive results1
  • No clear consensus or standardization exists to define next steps for atypical results, which can lead to missing early cancer diagnoses or unnecessary invasive tests.

hTERT ICC helps resolve atypical results

  • The hTERT test provides information that categorizes atypical results as low or high-risk.
  • Negative hTERT staining (< 10 urothelial cells) indicates a decreased likelihood that atypia is the result of urothelial carcinoma (UCC), although this cannot be ruled out.
  • Positive hTERT staining (≥ 10 urothelial cells) indicates an increased likelihood that cytological atypia is the result of urothelial carcinoma (UCC).

1 sample, 2 tests.

Valuable information without disruption. 

hTERT fits seamlessly into your existing laboratory workflow and instrumentation

 

One additional slide prepared with

StatPrep™ or ThinPrep®; both validated

Performed on ICC/IHC platforms

Quantum HDx® | Ventana | Leica

hTERT—your new cytology companion, exclusively available from StatLab.

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Clinical Testimonials

Adding urothelial hTERT testing to other clinical information can be valuable when determining the most appropriate follow-up for patients. With hTERT positivity, closer follow-up may be warranted even if other tests are negative for bladder cancer, as hTERT may be an early indicator that a low or even a high-grade cancer is present, or that one may be developing.  hTERT is not expected in normal, mature urothelial cells, so when detected, some additional investigation or monitoring may be beneficial to ensure nothing gets missed. On the other hand, a negative hTERT result, particularly in combination with other negative tests, can provide added confidence that cancer is less likely to be present. In some cases, there may be no further testing required at that time. Jed C. Kaminetsky M.D. Clinical Assistant Professor of Urology NYU School of Medicine New York, USA

 

Testing urothelial cells for the presence of hTERT is a great improvement over urine cytology alone. The presence of this biomarker is significant as it may be an indication of an early stage malignancy. This is particularly helpful if seen in cells that if not for the presence of hTERT, would be considered normal or at worst atypical, based on their appearance alone. Dr Michael Choi, Pioneer Cytopathologist Using hTERT ICC Since 2015, Memphis, USA

 

When positive, the test indicates an increased likelihood that either the patient has an existing UCC, or is at a higher risk of one developing, and the test increases the detection of lesions not well detected by UTC. Christopher VandenBussche M.D., Ph.D. , Associate Director, Cytopathology Division and Assistant Professor of Pathology at Johns Hopkins Hospital , Baltimore, USA

1. Brimo, F et al (2009) Accuracy of urine cytology and the significance of an atypical category Am J Clin Pathol 132:785-793.

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