The firm, which raised $7.1 million from its IPO last week, is looking to move into geographies where a need for infectious disease tests are already well established, its CEO said.
University of Washington scientists found that by adding a material first isolated from shellfish, they could increase the sensitivity of standard bioassays by up to 1,000 times.
The test detected Zika with sensitivity of 92 percent and specificity as high as 96 percent, making it potentially useful for diagnosing and monitoring the disease.
The assay is based on real-time reverse transcriptase PCR that will identify Zika in human serum or urine.
Chembio said that with the regulatory approval, its DPP Zika System, which includes an IgM/IgG assay, is now cleared for commercial use in Brazil.
An OpenArray panel designed to simultaneously test for 17 viruses and 13 bacteria and protozoa was able to detect pathogens from human blood donor samples with an accuracy of about 95 percent.
The company expects to use its centrifugal microfluidic platform to launch a dengue assay early in 2018 and a Zika-dengue assay later in 2018.
Along with the partnership to develop a portable detection device for Zika, Breathtec announced several management changes, including the resignation of its president.
The updated guidance comes on the heels of new data suggesting that for some individuals, antibodies to the Zika virus may stay in the body for months after infection.
The test was approved for lab use, but it runs on a platform with the potential for point-of-care applications.