With Sienna’s first product now in use with customers in the USA, the next stage is an IVD product release, followed by further market penetration and geographical expansion.– COO, Matthew Hoskin
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 registration of Sienna’s first product against telomerase means the SCD-A7 reagent can be used for clinical diagnostic purposes by pathology labs in the United States. Clinical pathology labs may now purchase SCD-A7 for use in their own laboratory developed in-vitro diagnostic tests. This is a significant world-first since never before has a telomerase-based assay been made available to the clinic for use in a laboratory developed IVD test.
Sienna’s focus is the development and commercialisation of innovative tests for use in clinical diagnostic laboratories worldwide.