Sorrento Therapeutics Inc. (NASDAQ: SRNE) has received approval for COVISTIX from the Brazilian regulatory agency (ANVISA). COVISTIX is a diagnostic tool that has the potential to be deployed in disease tracking and surveillance programs.
ANVISA issued COVISTIX with GMP approval
ANVISA issued COVISTIX good manufacturing practices approval which was published in the Official Journal of the Brazilian government on October 18, under registration CNPJ 17700763/0001-48 #3951. The marketing authorization approval in Brazil was published on November 3, 2021, under that registration with reference number 25351.041767/2021-72/8096180001.
Futura Ltd, a reputable direct point of care distribution and local hospitals partners for prescription pharmaceuticals and products, will hold the registration for Sorrento, with SYNOVA Ltd distributing the test to its network of diagnostic labs.
COVISTIX is a 15-minute)diagnostic test for detecting the nucleocapsid antigen of the SARS-CoV-2 virus in nasal samples of patients. Brazil has been heavily affected by the COVID-19 pandemic, with about 21 million illnesses and over 500,000 deaths to date. As a result, the government is aggressively working to improve testing capacities. However, despite active immunization campaigns, the need for testing remains significant, and it is vital in preventing novel variations of concern from spreading.
Following the approval, Sorrento will be in a position to offer a high-quality and economical diagnostic solution for Brazil. Furthermore, new data made available through an impartial third party compared COVISTIX to a prominent ex-USA quick diagnostic test positively, showing COVISTIX’s better sensitivity in a field investigation.
License to enable deployment of COVISTIX in Latin America
This license will enable rapid commercial deployment in Brazil and other Latin American nations with strong linkages to the Brazilian market.
Sorrento CEO and Chairman Henry Ji said, “We are very grateful to ANVISA for working with us closely on this approval for our COVISTIX diagnostic product in Brazil. We look forward to working even more closely with the government to help deploy our test at large scale. We have been building our manufacturing capacity in anticipation of EUA clearances in multiple countries in need of highly sensitive, and simple COVID-19 rapid antigen testing.”