Access Bio Launches Full-Scale Sales of COVID-19 Antibody Rapid Test Kits in Brazil

[Asia Economy Reporter Ji-hwan Park] Access Bio recently announced on the 29th that its COVID-19 antibody rapid diagnostic kit, which received approval from the U.S. Food and Drug Administration (FDA), has obtained emergency use authorization from Brazil's National Health Surveillance Agency (ANVISA).

The 'CareStart COVID-19 IgM/IgG' approved by ANVISA is the same product that recently received Emergency Use Authorization (EUA) from the U.S. FDA. It has demonstrated excellent performance with 100% sensitivity and 97.5% specificity, verified by the U.S. National Cancer Institute.

A company representative explained, "We were able to successfully complete product registration through cooperation with a major pharmaceutical company in Brazil, and local sales will also utilize the sales network of this pharmaceutical company."

Access Bio plans to participate in the Brazilian bidding market in collaboration with the said company upon this approval. The company representative emphasized, "Access Bio has grown through the malaria RDT bidding market for 20 years and meets all the important conditions in the bidding market, such as excellent product performance, large-scale production capacity, and rapid lead time."

Access Bio plans to sell the product not only in the bidding market but also in the private sector, including clinics, hospitals, and general companies (for employee diagnostics). Brazil ranks second worldwide after the United States, with approximately 2.45 million confirmed COVID-19 cases.

The company representative stated, "We have obtained sales approval in the most regulated markets, the United States and Brazil, and are ready to deliver products to customers," adding, "Moreover, the fact that the antibody diagnostic kit is produced in the United States is a significant competitive advantage."

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