FDA clears Qiagen bloodstream infection panel for U.S. market

Qiagen (NYSE: QGEN) announced that the U.S. Food and Drug Administration has cleared the QIAstat-Dx BCID GPF Plus AMR Panel, marking the company's entry into U.S. bloodstream infection diagnostics.

The panel detects 20 gram-positive bacterial and fungal pathogen targets, along with a pan gram-negative target and 10 genetic antimicrobial resistance markers, from positive blood culture samples in approximately one hour.

The clearance expands Qiagen's QIAstat-Dx platform into a fourth infectious disease area in the U.S., alongside existing panels covering respiratory, gastrointestinal, and central nervous system conditions. The QIAstat-Dx platform is available in more than 100 countries and had more than 5,200 cumulative placements as of the end of 2025.

According to the Centers for Disease Control and Prevention, an estimated 1.7 million adults in the U.S. develop sepsis each year.

"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."

A complementary panel targeting gram-negative pathogens, the QIAstat-Dx BCID GN Plus AMR Panel, is currently under FDA review. Qiagen described the cleared panel as the first member of a planned QIAstat-Dx bloodstream infection panel family for the U.S. market.

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