Skip to main content
Premium Trial:

Request an Annual Quote

FDA Clears Qiagen QiaStat-Dx Rapid Syndromic Respiratory Panel


NEW YORK – Qiagen announced Monday that it has received 510(k) clearance for a respiratory syndromic testing panel on the QiaStat-Dx system.

Called the QiaStat-Dx Respiratory Panel Plus, the multiplex qPCR assay detects 21 bacterial and viral pathogens, including SARS-CoV-2, from a single upper respiratory sample.

"This comprehensive diagnostic tool will improve patient care, support responsible antimicrobial stewardship, and reduce the burden on healthcare systems," said Fernando Beils, senior VP and head of the molecular diagnostics business at Qiagen.

The QiaStat-Dx system generates results in approximately one hour with one minute of hands-on time, while allowing users to view cycle threshold values and amplification curves.

Qiagen said it is working on expanding the testing menu for the system in the US with a panel to detect gastrointestinal pathogens currently under US Food and Drug Administration review. The firm has previously said it plans to submit its CE-marked meningitis and encephalitis panel to the FDA as well.

Qiagen acquired the syndromic testing system in 2018 along with a CE-marked respiratory panel and gastrointestinal pathogen panel in development. Its respiratory panel obtained FDA clearance in 2019. A respiratory panel with the addition of a SARS-CoV-2 target was CE-marked in March 2020 and granted Emergency Use Authorization two months later.

The FDA announced in 2021 that it would begin to transition EUAs to full marketing and regulatory approval, after granting de novo clearance to the BioMérieux BioFire FilmArray Respiratory 2.1 Panel earlier that year.

Qiagen recently launched the QiaStat-Dx Analyzer 2.0, an upgraded system with a remote results app allowing users to view, comment on, and confirm diagnostic test results from their desktop and mobile devices. It also markets a CE-marked higher-capacity system called the QiaStat-Dx Rise that supports up to 160 tests per day.