Product News: Promega custom manufacturing capabilities aid in rapid development of Co-Diagnostics’ coronavirus test

Logix Smart™ COVID-19 test CE marked & available in Europe four weeks after project initiation

26 Feb 2020


Promega Corporation has been recognized by Utah-based Co-Diagnostics, Inc. for the support Promega custom manufacturing provided in the rapid development and launch of the new Logix Smart™ COVID-19 Test. Co-Diagnostics announced its coronavirus test received CE mark approval and is now available in Europe as an in vitro diagnostic (IVD). The news comes roughly one month after Co-Diagnostics first began work on a test to detect SARS-CoV-2, the virus that causes COVID-19.

“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.”

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 their 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.

In 2016, Co-Diagnostics also worked with Promega to customize reagents for Zika virus testing.

Because Promega manufactures more than 4,000 life science and in vitro diagnostics products, the company can leverage its operations to create custom products for diagnostic manufacturers on very short notice. 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.

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