Johns Hopkins Present Positive Study Results For hTERT Test

  • 500 patient study confirms clinical utility of hTERT testing as an adjunct to urine cytology
  • Study results were presented by Johns Hopkins at USCAP meeting in Vancouver

StatLab is the proud exclusive distributor of Sienna Diagnostics IVD hTERT assay. Johns Hopkins University School of Medicine, recently presented the results of its study using Sienna’s in-vitro diagnostic (IVD) hTERT test at the United States and Canadian Academy of Pathology (USCAP) 2018 Annual Meeting.

The 500-patient bladder cancer study confirmed the clinical utility of the test as an adjunct to urine cytology. The results demonstrated an increase in sensitivity when using the hTERT test in conjunction with cytology. The sensitivity of standard urine cytology alone was 29%, whereas cytology combined with hTERT increased the sensitivity to 51%, while maintaining a specificity of 89%. As a result, the study concluded that hTERT testing may help to identify patients with increased likelihood of High Grade Urothelial Carcinoma (HGUC), who may otherwise be missed by standard screening alone. Additionally, negative hTERT staining was shown to be associated with a decreased risk of HGUC compared to cytology alone.

The USCAP Annual Meeting is a premier event for pathologists drawing over 5,000 attendees from almost 90 countries. This year’s conference is being held in Vancouver, Canada from March 17-23, 2018.

The results of the study were presented by Professor Christopher VandenBussche, Associate Director of Cytopathology and Assistant Professor of Pathology, and Dr. Morgan Cowan, Resident Pathologist, both of the Johns Hopkins University School of Medicine.

VP of Advanced Diagnostics, Dr. Mark Rees commented “StatLab is proud to be a partner with Sienna for the hTERT test as the exclusive US distributor for this assay. The Johns Hopkins study highlights the importance of this new adjunct test for increasing diagnostic sensitivity when used alongside cytology.”

In a video released below, Sienna’s CEO Matthew Hoskin discusses the positive findings of the Johns Hopkins clinical study investigating the use of the hTERT test as an adjunct to urine cytology for the investigation of bladder cancer.