Co-Diagnostics has announced the launch of the test after two weeks of adequate design, development, and verification activities
Render of 2019 nCoV virion (Credit: CDC/ Alissa Eckert, MS; Dan Higgins, MAM)
Molecular diagnostics firm Co-Diagnostics has introduced its CoPrimer test for the 2019-nCoV coronavirus.
The research use only (RUO) test can be used by appropriate laboratories, hospitals, and institutions to address the current coronavirus epidemic.
Co-Diagnostics has announced the launch of the test after two weeks of adequate design, development, and verification activities to assure the polymerase chain reaction (PCR) test’s performance meets the needs of a growing market for coronavirus detection.
CoPrimer verifies most optimal target on 2019-nCoV genome
The company has used its advanced process, including the CoDx Design software system, to design the test for quickly detecting and verifying the most optimal target on the 2019-nCoV genome for a PCR assay.
Co-Diagnostics said that it believes the unique design of the test will offer enhanced accuracy when identifying the presence of the coronavirus, including optimised specificity over tests designed on a different platform.
The new coronavirus, which is spreading quickly over the past several weeks, has been first detected in China’s Wuhan city on 7 January.
Since the detection of the new virus, the infections have been confirmed in 28 countries, including 12 patients testing positive in the US. To date, more than 28,000 cases have been registered and over 560 people were dead due to the virus.
Co-Diagnostics CEO Dwight Egan said: “Increased specificity is one of the hallmarks of tests built using our patented CoPrimer platform.
“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.”
Recently, the US Food and Drug Administration (FDA) has granted an emergency use authorisation (EUA) status for the first 2019 novel Coronavirus diagnostic test.
The EUA status enables to use of the Centers for Disease Control and Prevention’s (CDC) 2019-nCoV Real-Time RT-PCR diagnostic panel at any CDC-qualified lab across the US.