The national health-regulatory agency of Brazil has approved commercial use of Chembio Diagnostics’ rapid field rest for the Zika virus – a major step toward selling the product in the Zika-ravaged Brazilian market.
Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) has greenlighted the DPP Zika IgM/IgG Assay, which detects antibodies using a tiny drop of blood and provides “semi-quantitative results” in 15 minutes, according to the company, using Chembio Diagnostics’ patented virus-detection platform and a handheld, battery-operated DPP Micro Reader.
The agency must still approve use of the accompanying micro reader. But approval of the assay itself is huge for the Medford-based biotech – and for Brazil, where Zika virus is blamed for birth defects in more than 2,000 children.
Chembio Diagnostics CEO John Sperzel III said the company was “pleased to receive approval from Brazil’s health-regulatory agency” and looks forward to initiating sales after “successful evaluation” of the assay by the Instituto Nacional de Controle de Qualidade em Saúde – the South American nation’s National Institute of Health Quality Control – and AVISA’s approval of the DPP Micro Reader.
“We are currently involved with INCQS and ANVISA to accomplish these final steps,” Sperzel said in a statement.
The ANVISA approval is the first major South American announcement for Chembio Diagnostics since the company named Sharon Klugewicz president of its Americas region in October, giving the former COO direct control of Chembio’s Canadian, U.S. and Latin American markets.
Declining Latin American sales have plagued the company since the end of 2014, due largely to a drop in demand for its point-of-contact tests for sexually transmitted diseases.
It’s also the biggest Brazilian breakthrough for the Medford-based firm since March, when Chembio Diagnostics first announced its Zika collaboration with Bio-Manguinhos, the unit of the Oswaldo Cruz Foundation – the Rio de Janeiro-based biomedical R&D nonprofit – responsible for development and production of vaccines, diagnostics and biopharmaceuticals.
Domestically, Chembio Diagnostics was bolstered in August by a $13.2 million stipend from the U.S. Department of Health and Human Services to further develop its rapid Zika tests.