Qiagen is looking to steeply ramp up its worldwide production of the RNA test reagents used to perform certain COVID-19 diagnostics.
Previously, the Dutch diagnostics manufacturer turned out enough of the chemical mixture to supply about 1.5 million coronavirus tests per month. Now, Qiagen plans to scale up to support more than 6.5 million tests by the end of April, and more than 10 million per month by the end of June.
By the end of the year, the company hopes to provide for more than 20 million monthly tests through its manufacturing sites in the U.S. and Europe.
Qiagen told Politico earlier this month that these materials were on backorder due to sharp increases in the demand for coronavirus testing. Meanwhile, Robert Redfield, head of the Centers for Disease Control and Prevention, testified before Congress late last week saying that testing reagents industry-wide were beginning to go into short supply.
Qiagen’s kits are used to extricate RNA strands from the cells and viruses within a sample, and purify them so they can be sequenced and matched for signs of the novel coronavirus SARS-CoV-2, which causes the pandemic disease COVID-19.
The company’s products are a few of several that can be employed during testing steps for the diagnostic previously developed by the CDC, for example, alongside compatible reagents from Roche and bioMérieux, according to the FDA.
“Qiagen teams are working 24/7 to address the unprecedented demand for reagents that has emerged to enable testing for COVID-19 in terms of RNA extraction, as well as for production of tests for use on the QIAstat-Dx syndromic testing system,” Qiagen’s interim CEO Thierry Bernard said in a statement.
“We continue to work with our customers around the world to assess their flexibility, timing and quantity needs to support shipping of RNA extraction reagents to the most critical areas,” added Bernard, who also heads the company’s molecular diagnostics business.
Additionally, the company said it expects to receive regulatory clearances in both the U.S. and Europe in the coming days for its coronavirus panel on the QIAstat-Dx respiratory test platform. Qiagen previously received a grant from the U.S. Biomedical Advanced Research and Development Authority, known as BARDA, to support its development.