Co-Diagnostics, Inc. (Nasdaq: CODX), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that its Logix Smart™ Coronavirus COVID-19 Test has obtained regulatory clearance to be sold as an in vitro diagnostic (“IVD”) for the diagnosis of SARS-CoV-2 (COVID-19) in markets that accept CE-marking as valid regulatory approval, and is now available for purchase from the Company’s Utah-based ISO-13485:2016 certified facility.
The Declaration of Conformity for the Logix Smart COVID-19 test confirms that it meets the Essential Requirements of the European Community’s In-Vitro Diagnostic Medical Device Directive (IVDD 98/79/EC), permitting export and sales of the product as an IVD to commence immediately in the European Community. Co-Diagnostics shipped samples of the Research Use Only version of its test to distributors in Italy and Germany last week, which allows future customers to confirm the quality and sensitivity of the product prior to the IVD being available, and the Company to accelerate the sales efforts of its diagnostic. Many other global markets also accept a CE marking as valid regulatory approval following routine local product registration, which allows sales of the Company’s IVD into these areas.
Dwight Egan, Chief Executive Officer of Co-Diagnostics, remarked, “Co-Diagnostics has received overwhelming interest in our novel coronavirus diagnostic from all over the world since first announcing its development a month ago. As the disease has spread from China, so have concerns about the global health community’s ability to contain and control it. The first step in containment is a prompt, accurate diagnosis, and we are pleased to provide this product to those areas that are able to utilize a CE-marked IVD to protect their residents and visitors from a disease that has already affected millions.
“We believe Co-Diagnostics is the first U.S. company to receive a CE-marking for a coronavirus IVD, which is a testament to the quality of our platform. The rapid development of our COVID-19 test was made possible thanks to our proprietary design process and patented CoPrimer™ technology platform. We look forward to scaling up production to meet global demand with this regulatory clearance in place, and to obtaining approvals from other bodies that will allow us to further increase the reach of this invaluable diagnostic tool.”
Source: Company Press Release
