Co-Diagnostics, a US-based molecular diagnostics company, has secured the regulatory CE Mark approval for its Logix Smart Coronavirus COVID-19 Test.
The approval enables the test to be sold as an in vitro diagnostic (IVD) for the diagnosis of SARS-CoV-2 (COVID-19) in all markets accepting CE-marking.
Co-Diagnostics states that the test is now available for purchase from its Utah-based facility.
Last week, the company shipped a few samples of the Research Use Only version of its test to Germany and Italy for distributors to check its quality.
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Co-Diagnostics CEO Dwight Egan said: Co-Diagnostics has received overwhelming interest in our novel coronavirus diagnostic from all over the world since first announcing its development a month ago. As the disease has spread from China, so have concerns about the global health community’s ability to contain and control it.
“The first step in containment is a prompt, accurate diagnosis, and we are pleased to provide this product to those areas that are able to utilise a CE-marked IVD to protect their residents and visitors from a disease that has already affected millions.”
Last week, the firm submitted its Logix Smart COVID-19 Test technical file for CE Mark registration.
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.
Earlier this month, Co-Diagnostics launched a research use only (RUO) CoPrimer test for coronavirus (2019-nCoV).
Meanwhile, the number of deaths due to the novel coronavirus has neared 2,700, as of the end of 24 February. In mainland China, the number of new casualties was 71.
Positive cases have exceeded 80,000 globally, while the number of recoveries increased to more than 27,000.