Germantown, Maryland, and Venlo, Netherlands, August, 10, 2026
QIAGEN has received U.S. Food and Drug Administration (FDA) clearance for its QIAstat-Dx BCID GPF Plus AMR Panel, marking the company’s entry into bloodstream infection testing in the United States. The newly cleared molecular diagnostic panel is the first QIAstat-Dx bloodstream infection panel to receive FDA clearance and is designed to identify pathogens and antimicrobial resistance markers from positive blood cultures in approximately one hour. The development represents an important advancement in rapid infectious disease diagnostics, particularly for bloodstream infections that can progress quickly to sepsis, a life-threatening medical condition.
QIAstat-Dx Panel Targets Pathogens and Resistance
The QIAstat-Dx BCID GPF Plus AMR Panel is designed to detect 20 gram-positive bacterial and fungal pathogen targets, along with a broad pan gram-negative target and 10 genetic antimicrobial resistance markers. By combining pathogen identification with resistance-marker detection, the test is intended to provide clinicians with important diagnostic information soon after a positive blood culture becomes available. Rapid identification may support more informed treatment decisions, antimicrobial stewardship and infection-prevention strategies. The panel is designed to deliver results in about one hour, potentially giving healthcare teams critical information during the early management of serious bloodstream infections.
Bloodstream infections represent a major clinical challenge because they can deteriorate rapidly and lead to sepsis, in which the body’s response to infection can damage its own tissues and organs. According to the information provided by QIAGEN, approximately 1.7 million adults in the United States develop sepsis each year, highlighting the importance of timely diagnostic information. The company said the FDA clearance provides U.S. laboratories with an integrated approach for detecting pathogens and key genetic antimicrobial resistance markers, potentially helping healthcare professionals make faster and more informed decisions about patient care.
FDA Clearance Expands U.S. Infectious Disease Portfolio
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The FDA clearance also establishes the first member of a planned QIAstat-Dx bloodstream infection panel family in the United States. QIAGEN said a complementary QIAstat-Dx BCID GN Plus AMR Panel, focused on gram-negative pathogens and associated genetic antimicrobial resistance markers, is currently under FDA review. This planned expansion could broaden the company’s ability to address different pathogen groups associated with bloodstream infections through the same diagnostic platform.The QIAstat-Dx system integrates sample preparation, multiplex PCR testing and data analysis into a single workflow. The platform is designed to provide rapid, easy-to-interpret results while reducing hands-on laboratory work. QIAGEN reported that QIAstat-Dx is already available in more than 100 countries, with more than 5,200 cumulative placements as of the end of 2025. With the new bloodstream infection panel, the company is expanding the platform across four major infectious disease areas: respiratory, gastrointestinal, central nervous system and bloodstream infections.
The new FDA clearance strengthens QIAGEN’s position in molecular diagnostics and infectious disease testing, while giving U.S. laboratories another option for rapid analysis of positive blood culture samples. The company’s broader QIAstat-Dx portfolio includes respiratory, gastrointestinal and meningitis/encephalitis panels, creating a growing menu of tests on an integrated diagnostic platform. The addition of bloodstream infection testing is particularly significant because early recognition of pathogens and antimicrobial resistance can be important in clinical situations where treatment decisions may need to be made quickly.
Source: QIAGEN press release
