Johns Hopkins Study Published in Peer-Reviewed Journal

07-Jun-2018

Sienna is pleased to announce the results of the largest independent study to date using Sienna’s IVD test, conducted by Johns Hopkins Hospital, have been published in leading cytopathology journal Acta Cytologica.

  • Study was performed on 500 urine specimens, making it the largest to date
  • Published in Acta Cytologica, a leading cytopathology journal
  • Expected to result in increased uptake of Sienna’s hTERT test for routine clinical use
  • Article now available on-line at https://www.karger.com/Article/FullText/489181

The study, authored by researchers from the prestigious Johns Hopkins University School of Medicine in Baltimore, a world-renowned clinical and research hospital, concluded that testing urine samples for hTERT using Sienna’s IVD test is a clinically useful adjunct to urine cytology. It found the test may assist in the identification of patients who have an increased risk of bladder cancer.

The availability of the peer-reviewed data is important for driving market adoption. Sienna’s CEO Matthew Hoskin commented: “We believe the availability of this peer-reviewed study supporting the clinical utility of our IVD test will provide the extra level of confidence, assurance and validation needed for more laboratories to adopt the test for routine clinical use.”

When used as an adjunct to urine cytology, Sienna’s IVD had a significantly higher sensitivity to Low-Grade Urothelial Carcinoma (LGUC) compared to urine cytology alone. The test was shown to be most useful where a patient has a low-risk indeterminate urine cytology result, and a negative or absent cystoscopy result. A positive hTERT result may identify patients with an increased risk of bladder cancer who may otherwise not be monitored, while a negative hTERT result is associated with a reduction in the risk of bladder cancer.

“We are excited to see Sienna’s IVD test recognised and published on the world-stage. Inclusion in the well-respected, peer-reviewed publication Acta Cytologica, is a fantastic result, and widely read among the pathologists targeted by our distribution partners which is critical to adoption.”

To view the study publication, go to https://www.karger.com/Article/FullText/489181

 



 
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