Netherlands-based holding company QIAGEN N.V. (NYSE:QGEN) (Frankfurt Prime Standard:QIA) announced on Monday that it has received US Food and Drug Administration (FDA) clearance for a new QIAstat-Dx panel, giving US laboratories access to the company's complete bloodstream infection testing portfolio.

The QIAstat-Dx BCID GN Plus AMR Panel detects 13 gram-negative bacterial pathogens and 18 antimicrobial resistance markers, delivering results in about one hour.

The panel complements the QIAstat-Dx BCID GPF Plus AMR Panel, which detects gram-positive bacteria and fungi, bringing the combined portfolio to 33 pathogen targets and 28 antimicrobial resistance markers.

QIAGEN said faster identification of bloodstream infections can provide clinicians with information to guide treatment decisions, particularly because such infections can trigger sepsis, a potentially life-threatening response to infection.

The FDA clearance also expands the company's US QIAstat-Dx infectious disease testing menu, which includes respiratory, gastrointestinal, meningitis and encephalitis tests.

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