Co-Diagnostics, a molecular diagnostics company, has developed a research use only (RUO) CoPrimer test for the diagnosis of coronavirus (2019-nCoV).

The diagnostics firm said that its CoPrimer test is ready for sale to suitable laboratories, hospitals, and institutions, as a solution to the recent outbreak of coronavirus epidemic

In addition, the company has conducted two weeks of design, development, and verification activities to ensure the performance of the polymerase chain reaction (PCR) test.

Co-Diagnostics CEO Dwight Egan 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.”

Co-Diagnostics’ CoPrimer test accurately and specifically detects coronavirus

Co-Diagnostics said that it has designed the test using the CoDx Design software system, to rapidly identify and verify the most optimal target on the 2019-nCoV genome for a PCR assay.

In addition, the unique design of the test is said to deliver enhanced accuracy and improved specificity during the detection of coronavirus, compared to other tests designed on different platforms.

Following the outbreak of coronavirus in December 2019, the World Health Organization (WHO) has declared the novel coronavirus as a global health emergency on 30 January 2020.

The US Food and Drug Administration (FDA) has realised the potential of the virus to affect public health and authorised the emergency use of in vitro diagnostic (IVD) tests for the virus.

Co-Diagnostics said that it intends to commercialise its RUO test for immediate use, and is in contact with the regulatory agency for approval of its diagnostic test, on an emergency use basis.

Egan added: “If approved, it will allow us to commercialise 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.”