QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced that U.S. laboratories now have access to the complete QIAstat-Dx bloodstream infection portfolio following clearance of a new panel by the U.S. Food and Drug Administration (FDA).

The new panel detects gram-negative bacteria and antibiotic resistance markers in about one hour, complementing the recently FDA-cleared QIAstat-Dx panel for gram-positive bacteria and fungi.

Bloodstream infections can become serious very quickly and can trigger sepsis, a life-threatening response to infection that can lead to organ failure and death. According to the U.S. Centers for Disease Control and Prevention, about 1.7 million adults in the U.S. develop sepsis each year, and at least 350,000 die during hospitalization or are discharged to hospice. Faster identification of what is causing an infection can provide clinicians with important information to guide treatment decisions.

The new QIAstat-Dx BCID GN Plus AMR Panel identifies 13 gram-negative bacterial pathogen targets and 18 antimicrobial resistance markers. It complements the recently cleared QIAstat-Dx BCID GPF Plus AMR Panel, which identifies gram-positive bacteria and fungi.

Together, the two panels cover 33 pathogen targets and 28 antimicrobial resistance markers. The gram-negative panel covers 13 pathogen targets and 18 resistance markers, while the gram-positive and fungal panel covers 20 pathogen targets and 10 resistance markers. Both deliver results in about one hour.

The clearance also expands the QIAstat-Dx infectious disease testing menu in the U.S., which already includes tests for respiratory and gastrointestinal infections, as well as for meningitis and encephalitis.

“Bloodstream infections demand fast answers,” said Nitin Sood, Senior Vice President and Head of Product Portfolio & Innovation at QIAGEN. “With both panels now cleared in the U.S., laboratories can identify a broad range of pathogens and antibiotic resistance markers on the same QIAstat-Dx system. This can provide clinicians with timely information to support treatment decisions and address antibiotic resistance.”

QIAstat-Dx combines sample preparation, multiplex PCR testing and data analysis in a single automated workflow. The system is available in more than 100 countries, with more than 5,200 cumulative placements as of the end of 2025.