Logix Smart™ COVID-19 Test is authorized for emergency use by the FDA, and CE marked to be sold in Europe
Madison, WI USA. (April 16, 2020)
Promega Corporation has been contracted by Utah-based Co-Diagnostics, Inc. to support Co-Diagnostics’ efforts to manufacture test kits of its new Logix Smart™ COVID-19 Test. Promega originally provided the custom master mix used in the rapid development and launch of the coronavirus test, which received CE mark approval to be available in Europe as an in vitro diagnostic (IVD) roughly one month after development began. Recently, the test obtained FDA emergency use authorization (EUA) to expand sales within the United States. Test kits have also been shipped to countries around the world including Turkey, the Philippines, Thailand, Australia, Paraguay, Ecuador, Israel, South Africa, and Canada.
Promega Corporation will begin supplying complete test kits for further distribution by Co-Diagnostics. The enhanced partnership enables Co-Diagnostics to reach additional testing facilities while leaning on Promega Corporation’s extensive manufacturing capabilities and increased capacity.
“Promega’s commitment to the highest quality standards of manufacturing is part of what makes Promega not only such a well-known and respected provider of molecular diagnostic components, but also the ideal partner for manufacturing our coronavirus test kits,” said Dwight Egan, CEO at Co-Diagnostics. “Promega has shown its dedication to customer satisfaction time and again over the years, and we can be confident they will be instrumental in helping Co-Diagnostics meet the demand for our products.”
The Logix Smart COVID-19 Test uses Co-Diagnostics’ patented CoPrimer™ technology to detect the presence of ribonucleic acid (RNA) produced by the novel strain of coronavirus and can yield results in under two hours. The real-time RT-PCR kit targets conserved regions in the SARS-CoV-2 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 coronavirus disease outbreak and then pandemic, Co-Diagnostics used a custom master mix formulated with the Promega PCR Optimization Kit for coronavirus testing.
“As demand for Co-Diagnostics’ innovative Logix Smart™ COVID-19 test grows globally, Promega is providing a nimble approach to rapidly support increased, high quality manufacturing capacity of this test,” said Terri McDonnell, Global Strategic Marketing Manager at Promega. “With 40 years of experience in developing and manufacturing amplification reagents to suit our customers’ specific needs, Promega is well placed to quickly adapt to our partners’ requirements.”
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.
To learn more about Promega custom capabilities, visit www.promega.com/custom-solutions/custom-manufacturing/
About Promega Corporation
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. Founded in 1978, the company is headquartered in Madison, WI, USA with branches in 16 countries and over 50 global distributors. For more information about Promega, visit www.promega.com.