FDA Clears One-Hour Panel for Bloodstream Infection and AMR Detection

Bloodstream infections can rapidly progress to sepsis, a life-threatening condition affecting an estimated 1.7 million adults in the U.S. each year. Rapid identification of pathogens and antimicrobial resistance markers is critical for guiding treatment, supporting stewardship, and limiting transmission. To accelerate results from positive blood cultures, a newly cleared syndromic panel can identify organisms and 10 antimicrobial resistance (AMR) markers in about one hour.

QIAGEN’s QIAstat-Dx BCID GPF Plus AMR Panel has received U.S. Food and Drug Administration (FDA) clearance, the first QIAstat-Dx panel for bloodstream infections to receive FDA clearance. The clearance expands the platform’s U.S. syndromic menu into bloodstream infection diagnostics and establishes the first member of a planned blood culture identification (BCID) panel family. A complementary QIAstat-Dx BCID GN Plus AMR Panel designed for gram-negative pathogens is currently under FDA review.

The panel targets 20 gram-positive bacterial and fungal pathogens and includes a broad pan gram-negative target, together with 10 genetic AMR markers, from positive blood culture samples. Reported time to result is about one hour. The QIAstat-Dx system integrates sample preparation, multiplex PCR testing, and data analysis into a single workflow designed to reduce hands-on time and deliver easily interpretable results for laboratory professionals.

According to the company, bloodstream infections are associated with significant morbidity and mortality and can rapidly progress to sepsis, underscoring the need for timely diagnostic information. The rapid identification of pathogens and resistance gene markers can support more informed treatment decisions, antimicrobial stewardship, and infection prevention measures. In the U.S., the QIAstat-Dx menu spans respiratory, gastrointestinal, and central nervous system testing, and now includes bloodstream infections with this FDA-cleared panel.

“Every hour, even minutes, count with bloodstream infections. 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.,” said Nitin Sood, Senior Vice President and Head of Product Portfolio & Innovation at QIAGEN.