Company Making Coronavirus Kits In Germantown Can Now Ship To US

GERMANTOWN, MD — QIAGEN, the German molecular testing company with a large Montgomery County presence, announced on Tuesday that it has begun shipping its coronavirus testing kits to the United States.

It was made possible under a new policy laid out by the U.S. Food and Drug Administration that helped expand the number and variety of diagnostic tests in laboratories and other health care settings in the wake of the coronavirus pandemic.

The kits are being made at QIAGEN's U.S. headquarters in Germantown, Maryland.

The company says its new QIAstat-Dx Respiratory SARS-CoV-2 Panel test — which, a week ago, could only be purchased in the European Union — "can differentiate SARS-CoV-2 coronavirus from 20 other respiratory infections in patients who may have similar symptoms in a single testing run of about one hour."

The test, QIAGEN adds, evaluates samples such as nasopharyngeal swabs (from the back of the nose and throat) collected from patients who may have respiratory tract infections. Results can be ready in an hour.

"We are pleased to begin making QIAstat-Dx SARS-CoV-2 test kits available in the United States as the first syndromic test not only to detect SARS-CoV-2, but also a range of more than 20 other respiratory targets," said QIAGEN CEO Thierry Bernard. "This is an important step in our commitment to offer a range of solutions to support the public health fight against COVID-19 and dramatically ramp up production. Our teams have responded rapidly to the challenge, implementing 24/7 production of test components, adding staff and investing in expanding production capacity."

The release of this new diagnostic test comes nearly two weeks after the U.S. Department of Health and Human Services announced that QIAGEN would receive approximately $598,000 in funding for the project.