SugenTech Receives Approval from Brazil's National Health Surveillance Agency for COVID-19 Self-Test Kit

SugenTech COVID-19 Self-Test Kit.

[Asia Economy Reporter Lee Gwan-ju] SuzenTech announced on the 2nd that it has received approval from the Brazilian Health Regulatory Agency (Anvisa) for the use and sale of its COVID-19 self-diagnostic kit (SGTi-flex COVID-19 Ag).

The approved product is a rapid antigen self-test kit that collects samples through the nasal cavity, with a sensitivity of 95.06% and specificity of 99.29%. It is a product recently authorized by the Ministry of Food and Drug Safety and is actively sold domestically. Since 2020, SuzenTech has already been exporting professional-use products approved in Brazil.

In response to the surge in testing demand due to the spread of the Omicron variant, Brazil recently approved the sale of infectious disease diagnostic kits in pharmacies and supermarkets. SuzenTech’s self-test kit is the third personal self-diagnostic product to be approved in Brazil.

SuzenTech plans to supply products throughout Brazil through major pharmacy chains by forming a strategic partnership with local partners (Biosys / Kovalent do Brasil LTDA). Additionally, based on the established network, it is expected to greatly assist the entry of various personal care products such as pregnancy and ovulation tests into the Brazilian market.

A company representative stated, “In addition to Brazil, many South American countries are showing movements to approve self-test products,” and added, “We are focusing our capabilities on quickly obtaining approvals in line with market trends and needs.”

Previously, SuzenTech received approval for COVID-19 professional antigen test products in Colombia, Peru, and Bolivia in the South American region, and the COVID-19 and Influenza A/B simultaneous test product was approved in Mexico. Furthermore, to target the North American market, it has completed approval for professional diagnostic kits from Health Canada and is currently undergoing the U.S. FDA Emergency Use Authorization (EUA) review.

This content was produced with the assistance of AI translation services.