Co-Diagnostics, Inc. Receives CE Mark for Zika Screening Test

Co-Diagnostics, Inc. (Nasdaq: CODX), a molecular diagnostics company with a unique, proprietary platform for the development of molecular diagnostic tests, announced today that its Logix Smart Zika Test technical file has obtained CE mark approval, the principle regulatory clearance allowing the test to be sold as an in vitro diagnostic (“IVD”) for the diagnosis of Zika virus in European Union states and other markets that accept a CE-IVD mark as valid regulatory approval.

Dwight Egan, Chief Executive Officer of Co-Diagnostics, remarked, “The CE marking of the most recent iteration of our Zika test is a significant step towards meeting demand for disease detection products in one of our key target markets. Given the ability of Zika infections to be passed along through mosquito vectors as well as sexual transmission, the key component to preventing the occurrence of these tragic developmental disorders is an early, accurate, and affordable diagnosis for both men and women. Like many mosquito-borne illnesses, Zika infections tend to occur in cycles, but the World Health Organization (“WHO”) has recently emphasized that the threat of Zika has not abated. We are confident that this test meets our high standards of quality and performance and will allow us to better meet the demand for affordable Zika diagnostic options, the absence of which can have awful consequences for families and create additional burdens on social health programs.”

The CE mark confirms that the test meets the Essential Requirements of the European Community’s In-Vitro Diagnostic Medical Device Directive (IVDD 98/79/EC), allowing sales of the product to commence as an IVD with the CE marking included. The Logix Smart Zika Test uses polymerase chain reaction (“PCR”) technology to detect the presence or absence of the Zika virus in serum, plasma, collected alongside with urine, from patients suspected to be infected. While not lethal itself, studies have directly linked Zika with cases of microcephaly, a neurological disease that affects the brain development of fetuses. The WHO has raised the priority for R&D investments for Zika in their 2018 annual review of diseases.