In response to the rising demand for tests that detect the SARS-CoV-2 coronavirus, Qiagen plans to increase the output of its viral RNA extraction kits by as much as 50-fold compared to the company’s previous output.
According to 2019 figures, Qiagen supported approximately 400,000 tests a month with its RNA nucleic extraction reagents; this number was down compared to its historical capacity of supplying 1.5 million tests a month. However, by the end of April 2020, the company had produced enough reagents to support 7 million coronavirus tests.
This output is expected to rise even further in the coming months. According to a company-issued press release, Qiagen expects its reagent production capacity to support more than 10 million patient tests a month at the end of June 2020, and more than 20 million patient tests a month by the year’s end. The latter figure—resulting from a significant capacity expansion project underway at European and U.S.-based sites—represents a 13- and 50-fold increase in production, depending upon whether the baseline is 1.5 million or 400,000 tests, respectively. Additionally, Qiagen aims to increase the availability of kit-processing instruments in both research and clinical testing applications.
This news follows the announcement that Qiagen received emergency use authorization from the U.S. Food and Drug Administration for its QIAstat-Dx Respiratory SARS-CoV-2 Panel test. The syndromic testing solution is used for diagnosing patients infected with the COVID-19 coronavirus, and can differentiate the SARS-CoV-2 virus from 21 other respiratory pathogens. The panel provides test results in about an hour and runs on the QIAstat-Dx Analyzer, which has an installed base exceeding 1,200 systems worldwide in hospitals, laboratories and clinics. The test also received CE-IVD registration in Europe.
In other Qiagen news, the company announced first quarter 2020 net sales of $372.1 million, representing a growth rate of 7% or 9% at constant exchange rates (CER). For the second quarter, the company anticipates net sales growth of at least 12% at CER and adjusted earnings per share of at least $0.40 CER compared with the same period in 2019, driven largely by the surging demand for various products and solutions used in coronavirus pandemic testing. Furthermore, Qiagen has suspended its outlook for the full-year 2020 due to the uncertainties concerning the length and spread of the coronavirus pandemic, and the measures being taken to contain it.