NEW YORK – Qiagen said on Wednesday that it has received CE marking for its QiaStat-Dx Respiratory SARS-CoV-2 Panel to detect and differentiate SARS-CoV-2 and 21 other respiratory pathogens in symptomatic patients.
The panel becomes the first syndromic testing product commercially available in the EU and other territories accepting the CE mark. The real-time PCR test runs on Qiagen's sample-to-answer QiaStat-Dx platform and is designed to provide results from a patient nasopharyngeal swab in about an hour.
The new product builds on Qiagen's existing CE marked and US Food and Drug Administration-approved QiaStat-Dx Respiratory Panel, and includes two molecular targets specific to SARS-CoV-2: the ORF1b gene recommended by the Chinese Center for Disease Control and Prevention, and the N gene recommended by the US Centers for Disease Control and Prevention.
Other common viral and bacterial respiratory pathogens in the panel include four other coronaviruses, influenza A (and several subtypes), influenza B, Bordetella pertussis, Mycoplasma pneumoniae, and several parainfluenza viruses.
"We are pleased to launch the QIAstat-Dx SARS-CoV-2 test kits in Europe for clinical laboratories," Thierry Bernard, interim CEO and senior vice president and head of molecular diagnostics at Qiagen, said in a statement. "Qiagen is partnering with customers and public health authorities worldwide to provide a wide range of testing workflows, and the QIAstat-Dx syndromic panel adds an important tool for clinicians."
Qiagen also noted that it obtained derogation for the panel in Germany by the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), which means that the panel can be deployed immediately in that country, according to a company spokesperson.
Last week Qiagen said that it will receive $598,000 in funding from the US Department of Health and Human Services to develop a new version of the panel including the new coronavirus targets in the US for potential Emergency Use Authorization by the FDA.
Qiagen is in the process of being acquired by Thermo Fisher Scientific in an $11.5 billion deal.