New FDA-cleared panel completes the company’s U.S. QIAstat Dx bloodstream infection portfolio, helping laboratories identify bacteria and antibiotic resistance markers faster
Germantown, Maryland, 28 September 2026 – Bloodstream infections can become serious quickly, making timely testing important for healthcare teams. QIAGEN has expanded its diagnostic testing portfolio in the United States with a new panel for detecting Gram-negative bacteria and antibiotic resistance markers.
The company announced that the U.S. Food and Drug Administration has cleared the new QIAstat Dx BCID GN Plus AMR Panel. The clearance completes the company’s U.S. QIAstat Dx bloodstream infection testing portfolio, adding to the BCID GPF Plus AMR Panel that received FDA clearance in August 2026.
The new panel is designed to identify 13 Gram-negative bacterial pathogen targets and 18 antimicrobial resistance markers from positive blood culture samples. Results are available in about one hour, giving laboratories access to important information that can support faster clinical decisions.
Together, the two QIAstat Dx bloodstream infection panels cover 33 pathogen targets and 28 antimicrobial resistance markers. The combined portfolio covers Gram-positive bacteria, Gram-negative bacteria, fungi, and important genetic markers linked to antibiotic resistance.
Antimicrobial resistance is a growing challenge because some bacteria can become resistant to medicines that are normally used to treat infections. When a bloodstream infection involves resistant bacteria, identifying the pathogen and resistance markers quickly can help healthcare professionals make more informed treatment decisions and support responsible antibiotic use.
The QIAstat Dx system brings several laboratory steps into one workflow. It combines sample preparation, molecular testing, and data analysis, helping laboratories generate results without requiring multiple separate testing processes. The platform is already available in more than 100 countries, with more than 5,200 instruments placed worldwide by the end of 2025.
QIAGEN’s expansion also reflects the wider development of rapid molecular diagnostics. Faster testing can provide healthcare teams with useful information earlier, while supporting antimicrobial stewardship and infection control efforts.
With the latest FDA clearance, QIAGEN now has a broader U.S. testing offering across respiratory, gastrointestinal, central nervous system, and bloodstream infections. The company continues to expand the QIAstat Dx platform as healthcare laboratories look for faster and more integrated diagnostic solutions.