22nd October 2018 Content supplied by: Co-Diagnostics, Inc.
Logix Smart™ Zika Screening Test Receives CE Mark
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 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.
Mr. Egan continued, “Co-Diagnostics’ patented CoPrimer™ design platform, on which this test is built, has been shown to drastically reduce the occurrence of ‘primer-dimers,’ the often-occurring phenomenon that leads to false positives in PCR diagnostics. The groundbreaking multiplexing capabilities of CoPrimers is also being used to facilitate the development of another diagnostic test to identify and distinguish between Zika, dengue fever, and chikungunyua, three diseases with a high degree of comorbidity in regions where they are prevalent. We have already seen very promising verification results for this multiplexed screening test and look forward to being able to announce news related to its regulatory clearance in the near future, further augmenting our Company’s molecular diagnostics product offerings in underserved markets of the world.”
Co-Diagnostics will manufacture its Logix Smart Zika test in the Company’s ISO 13485:2016 facility for development and manufacture of IVD Medical Devices located in Utah, USA. At this time the Company is not seeking approval by the FDA for sale in the United States due to the low domestic rate of Zika incidents, and the test will be available on an Export Only basis.
Date Published: 22nd October 2018
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