Sienna reagent and cancer biomarker registered with FDA

The US FDA has registered the lead product of Melbourne-based biotech company Sienna Cancer Diagnostics - the antibody SCD-A7.

SCD-A7 is an antibody against telomerase, an enzyme which can be found in 80-90% of human carcinomas. This makes it a powerful biomarker for cancer.

Global pathology labs are now interested in accessing SCD-A7 to develop their own diagnostic tests, particularly for bladder cancer. Compared to the current detection method of cystoscopy, which can cost up to US$2000 per procedure, a simple urine test using the Sienna reagent is expected to cost less than US$150.

“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."

Sienna expects its first sales to major US pathology companies in the second half of 2014. The company is also in commercial and clinical discussions in Australia and Europe, while longer term distribution plans include South-East Asia, Canada and South America.

“There are few Australian companies that can boast that they have successfully completed an FDA registration," noted Dr Hegarty. “With more than 10 years of dedication to the development of groundbreaking telomerase-based diagnostics, registration of this product with the FDA and imminent first sales mark major milestones for Sienna."