Sienna Cancer Diagnostics Ltd. is a public unlisted company, with global operations based in Melbourne, Victoria. Head office and laboratories are located within the Small Technologies Cluster (STC), a successful and thriving environment where a number of biotechnology and other high technology businesses have their research and development, commercialisation and manufacturing operations.
Sienna’s strengths lie in identifying novel technologies then developing and commercialising them to satisfy an unmet clinical / market need. The team has proven skills and experience in navigating all elements of this complex pathway. This includes developing test formats that fit existing clinical paradigms and pathology workflows, utilising existing automation equipment, accessing existing reimbursement pathways, and optimising regulatory strategies, all focussed on getting product to the broadest possible market in the most timely and cost efficient manner.
Sienna has demonstrated the utility of its products with the help of its global clinical partners. Sienna’s primary platform is the detection of the biomarker, telomerase, which is found in nearly all epithelial cancers, and was the subject of a Nobel Prize in 2009.
The FDA listing of Sienna’s first IVD product means the SCD-A7 reagent can be used for clinical diagnostic purposes by pathology labs in the United States. CE marking and IVD registration in Europe and Australia means the same is true for those markets also. Clinical pathology labs in those regions may now purchase SCD-A7 for use as an in vitro diagnostic test for the presence of hTERT, a component of telomerase. This is a significant world-first since never before has a telomerase-based assay been made available to pathology laboratories for use on human clinical specimens.