The Bladder Cancer Diagnostic Market

The first application of Sienna’s IVD test is as an adjunct to urine cytology to assist in the diagnosis of bladder cancer. Urine cytology is a non-invasive test to investigate whether a patient may have bladder cancer. Typically, confirmatory diagnosis is made by a more invasive, expensive, and painful test - cystoscopy, where a tube is inserted through the urethra into the bladder so the bladder wall can be visually examined.

Urine cytology involves taking a urine sample for examination. It is difficult to detect low grade or early stage disease with urine cytology alone.

The cells from the bladder wall - called urothelial cells - are examined under a microscope. Early stage cancerous cells may have a normal appearance, or be only slightly atypical in size and shape, making it difficult to differentiate them from normal cells.

Taking urothelial cells from the urine sample collected for standard cytology testing, and staining them for the presence of hTERT using the Sienna test, provides the diagnosing urologist with useful adjunct information regarding those cells. The detection of telomerase could indicate early stage cancer, as the cell has upregulated telomerase as part of a malignant process.

It is Sienna’s aim that our IVD test for hTERT becomes a standard diagnostic tool, used alongside urine cytology whenever that test is used to investigate the possible presence of bladder cancer. Sienna estimates there are 1.5 million urine cytology tests performed annually in the United States, with the worldwide market for our test a substantially larger opportunity.


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