NEW YORK (360Dx) – Melbourne, Australia-based Sienna Cancer Diagnostics announced today it has entered an agreement that makes Inside Diagnósticos its exclusive distribution partner for Brazil.
The agreement gives Inside Diagnósticos the right to sell Sienna’s telomerase reverse transcriptase (hTERT) test to pathology labs for use as an adjunct to urine cytology, assisting pathologists and urologists in the diagnosis of bladder cancer.
Sienna noted that the product must be approved and registered with the Brazilian regulatory agency Agência Nacional de Vigilância Sanitária (Anvisa) prior to sales commencing in the country. The company said that the deal, its first in South America, nonetheless represents a "significant milestone" in its geographic expansion strategy.
Financial and other terms of the agreement were not disclosed.
Sienna CEO Matthew Hoskin said in a statement that the in vitro diagnostics market in Brazil represents a significant opportunity for Sienna and its hTERT test. He noted that Inside Diagnósticos is not only a distributor but also a reference laboratory that will perform the hTERT test and promote its availability directly to referring urologists.
For detection, the test uses an antibody targeted against the hTERT protein component of the telomerase complex.