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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.
The in vitro diagnostic test is an automated immunoassay that leverages chemiluminescence detection technology to detect Zika virus IgM antibodies in human sera.
Dubbed "Sherlock," the new technology has demonstrated potential in detecting viruses and bacteria as well as human SNPs and mutations in cell-free DNA.
The funding will go toward the development of an immunoassay that would detect IgM antibodies specific to the Zika virus.