Molecular diagnostics company Co-Diagnostics is seeking CE mark approval for its COVID-19 coronavirus test.
The company has submitted the technical file to the European Community for the registration of Logix Smart COVID-19 test.
According to the company, the coronavirus test is expected to be available by the end of this month as an in vitro diagnostic (IVD) in the markets that accept a CE mark as valid regulatory approval
Co-Diagnostics’ test uses CoPrimer technology to identify the presence of RNA of the novel strain of coronavirus in a real-time RT-PCR kit
The company’s coronavirus test uses CoPrimer technology to identify the presence of ribonucleic acid (RNA) of the novel strain of coronavirus in a real-time RT-PCR kit, which focuses on conserved regions in the virus genome.
The new coronavirus, which is spreading quickly over the past several weeks, has been first detected in China’s Wuhan city on 7 January.
As per the current data provided by Johns Hopkins Center for Systems Science and Engineering, the novel coronavirus infected more than 75,000 people and caused around 2,130 deaths.
The company will produce Logix Smart COVID-19 test at its Utah facility in the US. The facility develops and manufactures IVD medical devices.
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.”
Earlier this month, the company announced the launch of CoPrimer test for the 2019-nCoV coronavirus.
The research use only (RUO) test can be used by appropriate laboratories, hospitals, and institutions to address the current coronavirus epidemic.-NS Medical Devices