QIAGEN expands bloodstream infection testing portfolio

• QIAGEN received FDA clearance for its QIAstat-Dx BCID GN Plus AMR Panel for bloodstream infection testing in U.S. laboratories.
• The panel detects 13 gram-negative bacterial targets and 18 antimicrobial resistance markers in about one hour.
• QIAGEN said the clearance completes its U.S. bloodstream infection portfolio by adding the new panel alongside its existing gram-positive bacteria and fungi panel.

QIAGEN (NYSE:QGEN) received U.S. Food and Drug Administration clearance for its QIAstat-Dx BCID GN Plus AMR Panel, expanding access to its bloodstream infection testing portfolio for U.S. laboratories.

The new panel complements the recently cleared QIAstat-Dx BCID GPF Plus AMR Panel, creating a combined testing portfolio designed to identify a broader range of bloodstream infection pathogens and antimicrobial resistance markers.

The QIAstat-Dx BCID GN Plus AMR Panel identifies 13 gram-negative bacterial pathogen targets and 18 antimicrobial resistance markers, while the combined panels cover 33 pathogen targets and 28 resistance markers with results available in about one hour.

QIAGEN develops molecular diagnostic technologies and laboratory solutions, including the QIAstat-Dx platform used for infectious disease testing across multiple applications.

The company said the QIAstat-Dx system is available in more than 100 countries, with more than 5,200 cumulative placements reported by the end of 2025, and its U.S. testing menu includes respiratory, gastrointestinal, meningitis, and encephalitis panels.