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Co-Diagnostics Completes Submission of CE Marking Registration for COVID-19 Coronavirus Test
Company’s new Logix Smart™ COVID-19 Test expected to be available with CE marking in February 2020 SALT LAKE CITY--(BUSINESS WIRE)-- Co-Diagnostics, Inc.
About this update from Co-diagnostics, Inc.
[{"type":"text","content":"\nCompany’s new Logix Smart™ COVID-19 Test expected to be available with CE marking in February 2020\n\n SALT LAKE CITY--(BUSINESS WIRE)--\nCo-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™ COVID-19 Test technical file has been submitted for registration with the European Community, and that it is expected to be available later this month as an in vitro diagnostic (“IVD”) for markets that accept a CE marking as valid regulatory approval.\n\n\nDwight Egan, CEO of Co-Diagnostics, commented, “We are pleased to announce this milestone, which comes after weeks of hard work by our team at Co-Diagnostics to develop a high-performance diagnostic to help prevent the spread of the new strain of coronavirus. Our patented CoPrimer™ molecules have unique properties that lead to a significant reduction in false positive test results over other polymerase chain reaction (PCR) technologies, but will also allow for enhanced multiplexing, or identifying multiple targets at once, as we iterate the test to include other strains of coronavirus and mutations of COVID-19.”\n\n\nCo-Diagnostics’ Logix Smart COVID-19 Test uses the Company’s CoPrimer technology to detect the presence of ribonucleic acid (RNA) of the novel strain of coronavirus in a real-time RT-PCR kit that targets conserved regions in the virus genome. The virus was first identified in the Chinese city of Wuhan on January 7, before spreading to 25 more countries, infecting over 75,000 people, and causing nearly 2,130 deaths according to current data available on Johns Hopkins Center for Systems Science and Engineering. A representative for the US Centers for Disease Control and Prevention (CDC) said last week that in addition to the testing kits distributed by the CDC, it was critical for the private sector to develop diagnostics for COVID-19 that could be commercially scaled.\n\n\nMr. Egan continued, “The impact that this virus will have on the global economy and health of countless individuals continues to evolve. Co-Diagnostics is in the vanguard of commercializing diagnostics to help ameliorate the effects of COVID-19 by ensuring accurate diagnoses, and we are confident in our ability to scale to meet demand as necessary.”\n\n\nThe technical fil...