A Promega product could be used to help test for the novel coronavirus.
In March, the Fitchburg company increased its production of lab materials used to diagnose COVID-19, the highly contagious illness caused by the coronavirus. COVID-19 was declared a pandemic by the World Health Organization on March 11, and since then every U.S. state has closed its schools and most have issued some form of a stay-at-home order in hopes of preventing its spread.
Testing, meanwhile, has been limited, and that limitation has contributed to the spread of the lillness.
On Wednesday, April 1, Promega announced that one of its amplification reagents had earned Emergency Use Authorization approval from the Food and Drug Administration to be used by the federal Centers for Disease Control and Prevention to help test for the virus.
The reagent is one piece of the testing process, according to the release, as it allows scientists to make billions of copies of RNA from one disease sample.
“Thanks to the CDC for acting quickly to make additions to their protocol, labs now have one more CDC-approved master mi when performing (tests),” Heather Tomlinson, director of clinical diagnostics at Promega wrote in the release. “The Promega (system) expands the testing capacity in the U.S. by being another option for labs to use in the amplification process of the CDC’s testing protocol.”
According to a March blog post written by Promega vice president Chuck York, the company has kept large quantities of lab materials in storage and has since added shifts to produce the materials seven days a week.
York wrote that the company is paying its employees overtime and creating split shifts. The business is also delaying work on new product development and other activities as the number of cases begins to spike in Wisconsin.
Wisconsin had 2,578 confirmed cases as of April 7, about five times what it had two weeks earlier, according to the state Department of Health Services.
The first cases of COVID-19 were seen in China in late 2019, and the illness has since spread internationally, affecting nearly 1.5 million people and killing over 84,000, according to statistics from Johns Hopkins University.
Containing its spread has been difficult because of a long duration between contracting and showing symptoms – often as much as two weeks – meaning people can carry and transmit it to many people without knowing it.
Tests, however, have been in short supply, and in many cases, even people showing symptoms have been unable to receive one. On March 30 the DHS reported it was receiving about 2,000 tests per day.
“At Promega, we are hearing the needs and concerns of our scientific colleagues and partners, and we are doing all that we can to help alleviate them,” York’s blog post reads.
Promega’s materials support 15 testing kits globally, including the Logix Smart Coronavirus COVID-19 test developed by Co-Diagnostics in Utah, according to the blog post.
The Co-Diagnostics test, according to the University of Wisconsin-Madison Center for Quick Response Manufacturing, was approved for testing in Europe and was advancing toward clearance in the United States and India, the post states.