Co-Diagnostics Seeks CE Mark for its COVID-19 Coronavirus Test

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EM Coronavirus, causing SARS
Electron micrograph of Coronavirus, the cause of Severe Acute Respiratory Syndrome, SARS

Salt Lake City-based molecular diagnostics company Co-Diagnostics announced today that it submitted the technical file for its Logix Smart COVID-19 Test for registration with the European Community, and that the company expects the IVD to be available later this month in markets that accept a CE marking as valid regulatory approval.

“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,” said Dwight Egan, CEO of Co-Diagnostics, in a press release. “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.”

Co-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.

According to current data available on Johns Hopkins Center for Systems Science and Engineering, the virus has spread to 25 countries and infected more than 75,000 people, and  has caused 2,130 deaths. 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.

“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,” Egan continued.

The technical file dossier submitted includes a description of the test to support conformance to the CE marking standards, which will confirm that the test meets the Essential Requirements of the European Community’s In-Vitro Diagnostic Medical Device Directive (IVDD 98/79/EC). The registration process is expected to be complete later this month, at which point sales of the product may commence as a CE-marked IVD. Co-Diagnostics will manufacture its Logix Smart COVID-19 Test in the company’s ISO-certified facility for the development and manufacture of IVD medical devices located in Utah.

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