Promega Custom Manufacturing Capabilities Aid Rapid Development of New Coronavirus Test from Co-Diagnostics

Promega Corporation’s (Madison, WI, USA) custom manufacturing capabilities have helped Co-Diagnostics, Inc. (Salt Lake City, UT, USA) in the rapid development and launch of its new Logix Smart™ COVID-19 Test which has received CE mark approval and is now available in Europe as an in vitro diagnostic (IVD). The development comes about one month after Co-Diagnostics first began working on a test to detect SARS-CoV-2, the virus that causes COVID-19.

Promega Corporation is a leader in providing innovative solutions and technical support to the life sciences industry. The company’s 4,000 products enable scientists worldwide to advance their knowledge in genomics, proteomics, cellular analysis, drug discovery and human identification. Promega manufactures more than 4,000 life science and in vitro diagnostics products, which allows the company to leverage its operations for creating custom products for diagnostic manufacturers at a very short notice. The implementation of Quick Response Manufacturing (QRM) principles, including co-locating a cross-functional team to evaluate inquiries, process orders, and answer questions, allows Promega to act rapidly with a high level of customer service, which is crucial when responding to emergent outbreaks such as SARS-CoV-2.

Co-Diagnostics is a molecular diagnostics company that develops, manufactures and markets a new, state-of-the-art diagnostics technology. The company’s technology is utilized for tests that are designed using the detection and/or analysis of nucleic acid molecules (DNA or RNA). The company also uses its proprietary technology to design specific tests to locate genetic markers for use in industries other than infectious disease and license the use of those tests to specific customers.

The Logix Smart COVID-19 Test uses Co-Diagnostics’ CoPrimer technology to detect the presence of ribonucleic acid (RNA) produced by the novel strain of coronavirus. The real-time RT-PCR kit targets conserved regions in the genome. Promega has worked with Co-Diagnostics over the last five years to develop a custom master mix optimized for CoPrimer assay parameters. In response to the recent coronavirus disease outbreak, Co-Diagnostics used the Promega PCR Optimization Kit to refine its custom master mix for coronavirus testing. The Promega Custom Operations team then manufactured, QC tested, dispensed and packed the customized PCR assay reagents under the highest quality standards (cGMP) in less than 10 business days.

“After comparing with other commercially-available master mixes, Promega’s highly specialized offerings in custom manufacturing provided the best formulation for facilitating detection of SARS-CoV-2, and their dedication to customer support was instrumental in bringing a detection solution to the market,” said Dwight Egan, CEO at Co-Diagnostics. “Promega proved to be an invaluable partner, enabling us to rapidly deliver high-quality diagnostic solutions using our patented CoPrimer™ technology. Our business model demands that we work with a manufacturer that can re-prioritize quickly, enabling a truly rapid response to emerging infectious diseases, and Promega provides us that high level of service.”

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Promega Corporation
Co-Diagnostics, Inc.