What We Do And Why We Exist

We are a medical technology company that develops and commercialises novel diagnostic tests for the pathology market. The first product launched by Sienna is the first in-vitro diagnostic (IVD) test for the detection of hTERT, a component of the cancer-related biomarker, telomerase. While telomerase is well recognised and understood, there has never been a diagnostic test available to detect its presence in specific cells of interest.

In the world’s largest market for IVD products, the USA, our product is commercially available and actively marketed and sold through our distribution partner, StatLab Medical Products. Sales growth in this key market is a high priority for both Sienna and StatLab.

The need for products such as our IVD for hTERT is driven by these factors:

Cancer remains a significant global problem:

  • Cancer is one of the leading causes of morbidity and mortality worldwide, with ~14 million new cases recorded in 2012. The number of new cases is expected to rise significantly over the next two decades.
  • Cancer is the second leading cause of death globally, responsible for almost nine million deaths in 2015. Globally, cancer is the cause of nearly 1 in every 6 deaths.
  • The economic impact of cancer treatment and diagnostic testing is increasing, with the total cost estimated as US$1.16 trillion in 2010.

Early detection is helpful:

  • Cancer mortality can be reduced if cases are detected and treated early. When diagnosed early, cancer is more likely to respond to treatment, which can result in a greater probability of survival, and reduced treatment costs.

With a significant market opportunity, which is expected to increase in the years to come, Sienna will pursue commercial growth through several strategies:

  • Driving uptake of the test in the USA
  • Geographical expansion into new countries for the existing product in its initial application as an adjunct to urine cytology.
  • Application expansion for the product into new specimen types for assisting the detection of other cancers.
  • Product expansion of Sienna’s commercialisation pipeline through acquisition or in-license of new technologies.

“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, Cytopathologist


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