Molecular diagnostics company Co-Diagnostics has signed an agreement with Promega for additional manufacturing capacity for the urgent production of its Logix Smart Covid-19 test.
To help Co-Diagnostics meet the increasing demand for its Covid-19 test kits globally, Promega will provide manufacturing support for the company.
Co-Diagnostics currently supplies the test to customers in five continents and multiple locations in the US.
In addition, the company is involved in an initiative called Test Utah that aims to dramatically increase the rate of Covid-19 testing in Utah.
The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for the test earlier this month. The company is currently expanding its domestic outreach to public and private laboratories in the country to scale up manufacturing.
Co-Diagnostics CEO Dwight Egan said: “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.
“Promega has shown its dedication to customer satisfaction time and again, with branches in 16 countries and over 50 global distributors. We are confident they will be instrumental in helping Co-Diagnostics meet the growing demand for our products as we connect with even more laboratories and testing centres in the United States and abroad.”
Logix Smart Covid-19 test uses Co-Diagnostics’ CoPrimer technology to target the RdRp gene of the SARS-CoV-2 virus that causes the disease.
In February, the company secured a regulatory CE Mark approval for the test, allowing its sale as an in vitro diagnostic (IVD) for the diagnosis of coronavirus in all markets accepting CE-marking.
The test is currently available to all clinical laboratories certified under Clinical Laboratory Improvement Amendments (CLIA).