Co-Diagnostics Inc (NASDAQ:CODX) is on the receiving end of good news as its Logix Smart COVID-19 test, which detects the deadly coronavirus, is close to being rolled out across the European Union after being submitted for formal EU registration.
This novel test uses the Utah diagnostics company’s CoPrimer technology to identify the presence of a ribonucleic acid (RNA) associated with a new strain of the sometimes fatal virus, which first struck in the city of Wuhan in China late last year. The virus has since spread from China to infect more than 75,000 people and cause nearly 2,130 deaths, according to data cited by Johns Hopkins Center for Systems Science and Engineering.
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The coronavirus diagnostic test is expected to be available this month in European countries which accept the highly sought-after 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,” says Dwight Egan, CEO of Co-Diagnostics.
“Our patented CoPrimer molecules have unique properties that lead to a significant reduction in false positive test results over other polymerase chain reaction (PCR), 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.”
The dossier with the relevant technical file, which was submitted to the Utah company’s European representative, includes a description of the test to support its compliance with the necessary standards to win a CE mark. This information will confirm the test meets the requirements of the European Union’s In-Vitro Diagnostic (IVD) Medical Device directive.
Co-Diagnostics will manufacture its coronavirus diagnostic test in a plant set up for the manufacturing of IVD medical devices in Utah.
Earlier this month, Co-Diagnostics’ coronavirus diagnostic test caught the eye of analysts at Maxim Group. Enthusiastic about its introduction in China, Maxim analysts tagged the company with a Buy rating and increased its price target to $5 from $2, citing the speed at which the company developed the detection test and its first sales in China.
Co-Diagnostics shares moved 6.3% higher to hit $3.20 in afternoon trade on Thursday.