Dutch molecular diagnostics company Qiagen said Tuesday it would “dramatically” ramp up production of the components needed for the RNA extraction kits used to detect the novel coronavirus in a patient sample.
Isolating genetic material from a biological sample is a key step in the testing process, which has not been widespread in the US due to a number of factors including limited availability of the extraction kits.
Historically Qiagen (NYSE: QGEN) said it had the capacity to make enough of the components needed to perform the extraction process—reagents—for about 1.5 million patient tests monthly. In ramping up production the company now aims to enable more than 6.5 million patient tests a month by the end of April and 10 million patient tests by the end of June. By year’s end it aims to reach more than 20 million.
Qiagen said the work to expand capacity is underway at sites in Europe and in the US.
A lack of reagents has proven a troublesome bottleneck when it comes to expanding the number of tests available to patients in the US, stymying the total available including at academic labs such as UC San Diego Health, which has developed its own test. Other countries are facing the same challenge.
Qiagen—which is set to be acquired by Waltham, MA-based Thermo Fisher Scientific (NYSE: TMO) for about $11.5 billion—also said it anticipates a test it developed to detect evidence of SARS-CoV-2, which causes COVID-19, to soon be cleared for sale in the European Union. Qiagen said it is talking with the FDA, which has to date approved tests developed by Swiss biopharma Roche and Thermo Fisher, in an effort to get US approval, too.
The company was awarded $598,000 by the Biomedical Advanced Research and Development Authority, a division of the US Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, to accelerate development of its test kit.
Qiagen, with about 5,100 employees in 35 locations worldwide, reported revenue of $1.53 billion in 2019. The company anticipates the acquisition deal to close in the first half of 2021.
Image: iStock/Christoph Burgstedt