Original from: QIAGEN
QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has cleared the QIAstat-Dx BCID GPF Plus AMR Panel, the first QIAstat-Dx panel for bloodstream infections to receive FDA clearance.
The clearance expands QIAGEN’s U.S. syndromic testing portfolio into bloodstream infection diagnostics, the fourth major infectious disease area covered by the QIAstat-Dx platform, which is available in more than 100 countries and with more than 5,200 cumulative placements as of the end of 2025.
The QIAstat-Dx BCID GPF Plus AMR Panel detects 20 gram-positive bacterial and fungal pathogen targets as well as a broad pan gram-negative target together with 10 genetic antimicrobial resistance markers from positive blood culture samples in about one hour. The rapid identification of pathogens and resistance gene markers can support informed treatment decisions, antimicrobial stewardship and infection prevention measures.
Bloodstream infections are associated with significant morbidity and mortality and can rapidly progress to sepsis, a life-threatening reaction to an infection that causes your immune system to harm healthy tissues and organs. An estimated 1.7 million adults in the U.S. develop sepsis each year1, highlighting the importance of providing clinicians with timely diagnostic information.
“Every hour, even minutes, count with bloodstream infections,” said Nitin Sood, Senior Vice President and Head of Product Portfolio & Innovation at QIAGEN. “This clearance gives U.S. laboratories a fast and integrated way to identify pathogens and key genetic antimicrobial resistance markers, supporting more informed treatment decisions and responsible antibiotic use. It also establishes the first member of a broader QIAstat-Dx bloodstream infection panel family planned for the U.S.”
The QIAstat-Dx system integrates sample preparation, multiplex PCR testing and data analysis into a single workflow. It is designed to provide rapid and easy-to-interpret results while reducing hands-on time for laboratory professionals.
The FDA clearance also lays the foundation for the continued expansion of QIAGEN’s bloodstream infection testing portfolio in the U.S. A complementary QIAstat-Dx BCID GN Plus AMR Panel, designed to detect gram-negative pathogens and associated genetic antimicrobial resistance markers, is currently under FDA review.
QIAGEN has been consistently expanding the QIAstat-Dx menu for the U.S., broadening the platform across four major infectious disease areas: respiratory, gastrointestinal, central nervous system and now bloodstream infections. The portfolio includes the QIAstat-Dx Respiratory Panel Plus, the QIAstat-Dx Respiratory Panel Mini, the QIAstat-Dx Gastrointestinal Panel 2, the QIAstat-Dx GI Panel 2 Mini B, the QIAstat-Dx GI Panel 2 Mini B&V, the QIAstat-Dx Meningitis/Encephalitis Panel and the newly FDA-cleared QIAstat-Dx BCID GPF Plus AMR Panel. This reflects QIAGEN's strategy of building a comprehensive infectious disease testing menu on a single integrated platform.
Source: QIAGEN Receives U.S. FDA Clearance for First QIAstat-Dx Bloodstream Infection Panel
