Chembio Diagnostics Inc. is one step closer to selling its rapid test for Zika in Brazil, where the virus has been blamed for birth defects in 2,000 children, executives said Tuesday.
The Medford-based manufacturer announced that it has “received approval for commercial use” of its Zika point-of-care test from Brazil’s health regulatory agency, Agência Nacional de Vigilância Sanitária, or ANVISA.
The agency still must OK use of a companion reader to the test. The test also has to be evaluated by Brazil’s National Institute for Quality Control in Health, or INCQS.
Chembio CEO John Sperzel said he hopes the Zika test and reader will receive final approval soon, “especially as we approach December and the start of summer in Brazil” when mosquitoes are most active.
Zika is primarily spread through mosquito bites.
Chembio has been working all year on the Zika test with Bio-Manguinhos, a division of the Oswaldo Cruz Foundation. The division is responsible for providing vaccines and diagnostic tests to Brazil’s public health system.
Brazil is a Zika hot spot, with more than 1.5 million people infected with the virus, according to the World Health Organization.
Chembio shares closed at $6.90 Tuesday, unchanged from Monday.