The company’s announcement follows two weeks of efficient design, development, and verification activities to ensure that the polymerase chain reaction (PCR) test’s performance, first announced on January 23, meets the requirements of a large and growing market for coronavirus detection.
The test was designed using the company’s proprietary process, including the CoDx Design software system, to rapidly identify and verify the most optimal target on the 2019-nCoV genome for a PCR assay.
Co-Diagnostics said it believes that the test’s unique design will provide enhanced accuracy when detecting the presence of the coronavirus, including improved specificity over tests designed on a different platform.
“Increased specificity is one of the hallmarks of tests built using our patented CoPrimer platform,” said CEO Dwight Egan in a statement.
“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.”
He added: “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.”
An outbreak of respiratory illness caused by the pneumonia-like coronavirus has spread rapidly over the past several weeks, after first being identified in the Chinese city of Wuhan on January 7.
Since that time, infections have been confirmed in 28 countries, including 12 patients testing positive in the US, with over 28,000 cases worldwide (over triple that of SARS in 2002 and 2003), and over 560 confirmed deaths, nearly all located within China.
The World Health Organization declared the novel strain of the coronavirus a global health emergency on January 30, and on February 4 the US Food and Drug Administration granted authorization for emergency use of in vitro diagnostic (IVD) tests for the virus, after determining that the virus has significant enough potential to affect national security or public health.
Egan continued: “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.”
Co-Diagnostics’ stock closed up 19% to $3.08 a share in New York and ticked up 1% further in after-hours trading.
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