The QIAstat-Dx BCID GPF Plus AMR Panel has become the first QIAstat-Dx panel for bloodstream infections to receive U.S. Food and Drug Administration (FDA) clearance, according to a QIAGEN announcement.

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. 

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.

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