TGA Lists Sienna's IVD Product For Sale in Australia
Sienna has completed its third major regulatory milestone for the quarter, receiving Therapeutic Goods Administration (TGA) listing on the Australian Register of Therapeutic Goods (ARTG) for the sale of its Class 2 IVD in Australia.
The product is an antibody that binds to the human telomerase reverse transcriptase (hTERT) protein of the biomarker telomerase. It is Sienna’s first product to be launched in the Australian market.
hTERT can be recognised in cytological specimens by Sienna’s Anti-hTERT Antibody (SCD-A7) using immunocytochemistry (ICC). Importantly, the presence of hTERT in urothelial cells shed from the bladder wall into urine, can be detected in this way.
Pathology laboratories throughout Australia will now be able to purchase this product for use as an adjunct to urine cytology testing, which is a routine test performed as part of the diagnosis of bladder cancer.
“As a Melbourne based biotech company, we are thrilled to launch this technology to the Australian market. The additional information that our test provides to urologists will become an important adjunct to other tests and information used in the diagnostic workup. Ultimately, we hope to see the real benefits of this test being realised by patients”, said Sienna Chief Operating Officer, Matthew Hoskin.