Chembio Diagnostics Inc. announced Tuesday its test for the infectious disease dengue has been approved by Brazil’s health regulatory agency.
The Medford-based manufacturer said Agência Nacional de Vigilância Sanitária (ANVISA) has given the OK for use of the new blood test, which was developed with another Brazilian government agency, Bio-Manguinhos.
“We are pleased to receive ANVISA approval for our dengue test, which shows high sensitivity and specificity, especially considering that the number of dengue cases in Brazil tripled ... [in 2019] compared to last year,” said Chembio CEO John J. Sperzel.
“We now have multiple point-of-care tests available in Brazil and look forward to fulfilling the recently announced initial order from Bio-Manguinhos for our dengue, chikungunya and Zika tests.”
That combination test was approved last month and also was the product of a Chembio/Bio-Manguinhos collaboration.
Chembio has been working with Brazilian officials for some time to combat the spread of dengue, Zika and other illnesses in South America’s largest nation.
Dengue, which is spread by female mosquitoes, strikes nearly 400 million people per year, according to the World Health Organization. Nearly 4 billion people in 128 countries are at risk of the infection, which causes flu-like symptoms.
In Brazil, almost 600,000 dengue cases have been reported so far this year, according to the Pan American Health Organization. The disease can be fatal in children.
The announcement came before the stock market opened. Chembio shares finished Tuesday up 1.7 percent at $7.36 on the Nasdaq Stock Market.