Reagent enables a urine test for bladder cancer

Sienna Cancer Diagnostics, a Melbourne-based biotechnology company, has successfully registered its lead product, Anti-hTERT antibody (SCD-A7), with the US Food and Drug Administration (FDA). SCD-A7 is an antibody against telomerase, an enzyme which can be found in 80-90% of human carcinomas.

Given the power of the telomerase biomarker in correlating with malignancy, global pathology labs are interested in accessing SCD-A7 to develop their own diagnostic tests. The registration of the reagent makes this a possibility, with Sienna expecting first sales in the second half of 2014.

“US pathology labs will soon be the first in the world to be able to offer patients a urine test for bladder cancer developed using our product,” said Dr Kerry Hegarty, Sienna’s managing director and CEO. “Data from Sienna’s in-house clinical studies indicated potential benefits of SCD-A7 over other current testing procedures. Those results, combined with the non-invasive nature of the test, represent an important innovation, both for clinicians and patients.”

Cystoscopy is currently the industry standard for the diagnosis and monitoring of bladder cancer and can cost up to US$2000 per procedure. Simple, non-invasive urine tests using the Sienna reagent may assist in early detection, with an expected cost of less than US$150 per test.

In addition to commercial progress in the US, Sienna is in commercial and clinical discussions in Australia and Europe. Longer term distribution plans include South-East Asia, Canada and South America.

“The growing Sienna team and our valued US advisors deserve enormous praise for ensuring the expert management of the FDA registration,” said Dr Hegarty. “On behalf of the team, I’d also like to acknowledge the Australian Government for its Commercialisation Australia program, which leveraged shareholder investment and expedited much of this work.”