Novel coronavirus diagnostic test : Co-Diagnostics, a US molecular diagnostics company, said that its research use only (RUO) CoPrimer test for the 2019-nCoV coronavirus is ready for sale to laboratories, hospitals, and institutions.
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The molecular diagnostics company claims to have taken two weeks for the design, development, and verification activities of the diagnostic test for novel coronavirus to ensure that the performance of the polymerase chain reaction (PCR) test addresses the requirements of the market for coronavirus detection.
The Novel coronavirus diagnostic test was designed using Co-Diagnostics’ CoDx Design software system and other processes, to quickly identify and verify the most optimal target on the 2019-nCoV genome for a polymerase chain reaction assay.
Co-Diagnostics believes that the design of its diagnostic test for novel coronavirus will give improved accuracy when detecting the presence of the deadly virus, including better specificity over tests designed on a different platform.
Commenting on the CoPrimer diagnostic test for novel coronavirus, Dwight Egan -CEO of Co-Diagnostics, said: “Leveraging our proprietary design process and software has allowed us to quickly move this product from design into commercialization, and to do so with the confidence that our high-quality product meets our goal of providing an effective, much-needed global diagnostic solution in an emergency situation.
“As a result of our rapid development, we have already received requests from customers in countries across the world to purchase tests. Sales and shipments of products will be fulfilled from our Utah headquarters to customers who have the capacity to utilize RUO products to slow the spread of this epidemic.”
Novel coronavirus originated from Wuhan in China in late December 2019. Since then, the Wuhan coronoavirus has officially infected more than 28,000 people, while taking the lives of at least 560, mostly in China.
In the US, there have been 12 people who had tested positive to novel coronavirus. Know about the novel coronavirus cases in the US here.
Earlier this month, the US Food and Drug Administration (FDA) gave authorization for emergency use of in vitro diagnostic (IVD) tests for Wuhan coronoavirus, after determining that it has significant enough potential to impact national security or public health.
Dwight Egan said: “We are pleased to be able to react so quickly and commercialize this RUO version of our test that can immediately be used by thousands of labs around the world.
“We are already in communication with the FDA regarding clearance of our 2019-nCoV test on an emergency use basis. If approved, it will allow us to commercialize the test as an IVD, reaching even more markets affected by this disease.
“We are also pursuing a CE marking for the European Union and any country or jurisdiction that allows registration of IVD products that bear a valid CE marking, as well as emergency use clearance in India for our manufacturing joint venture in that country.”
Meanwhile, some of the pharma giants have started working on developing vaccines for coronavirus. Apart from that, several companies have been launching diagnostic tests for novel coronavirus, which includes a California-based metagenomics technology company called IDbyDNA which claims that its Explify Respiratory test can detect the Wuhan coronavirus.