NEW YORK (GenomeWeb) — Co-Diagnostics announced today that it has received CE-IVD marking for its Logix Smart ZDC multiplex test for the diagnosis of Zika virus, dengue fever, and chikungunya infection.
The PCR-based test is designed to identify and differentiate between Zika, all four serotypes of dengue, and chikungunya in serum samples, even in the presence of more than one target. It is available for purchase through Salt Lake City, Utah-based Co-Diagnostics' ISO 13485-certified facility.
The company noted that the CE-IVD marking permits the sale of the Logix Smart ZDC assay in the EU and other areas that recognize the designation, including a number of regions in the Caribbean basin and Latin America where it has distribution deals in place.
"This highly-specific diagnostic for three harmful diseases at once is possible due to our patented CoPrimer design platform enabling a massive reduction in false positives, which is especially important — but notoriously more difficult — in multiplexed assays of related pathogens," Co-Diagnostics CEO Dwight Egan said in a statement.
Co-Diagnostics has been focused on developing markets since its 2017 initial public offering and has stated that it will not seek US approval for certain of its tests — including its standalone Zika and tuberculosis assays — due to low domestic rates of infection.