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US-based molecular diagnostic company Co-Diagnostics has submitted its Logix Smart COVID-19 Test technical file for CE Mark registration.
The firm expects the CE marking later this month as an in vitro diagnostic (IVD) for markets that consider a CE marking as valid approval.
Logix Smart COVID-19 test uses the company’s CoPrimer technology to identify the presence of ribonucleic acid (RNA) of the novel coronavirus in a real-time RT-PCR kit that targets conserved regions in the virus genome.
Co-Diagnostics CEO Dwight Egan said: “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.”
Co-diagnostics stated that the submitted technical document contains the 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).
Upon registration process completion later this month, the sale of the product may commence as CE-marked IVD.
Earlier this month, Co-Diagnostics launched a research use only (RUO) CoPrimer test for coronavirus (2019-nCoV).
Coronavirus deaths have climbed to 2,247, including 2,236 recorded in Mainland China, as of the end of 20 February. In Hubei province, the total number of deaths stands at 2,144.
The total number of confirmed cases increased to more than 76,000, with more than 75,400 in mainland China. The total number of recoveries exceeded 18,400.
In mainland China, the number of recoveries increased to 18,264, with 5,206 suspected cases.