QIAGEN Strengthens Infectious Disease Testing Menu With FDA-Cleared Bloodstream Infection Panel

QIAstat-Dx, scan cartridge, Labworker handling the instrument, syndromic testing, Julian Phillips, Amit Singh, mask, wearing masks, labcoat

(IN BRIEF) QIAGEN has received U.S. FDA clearance for the QIAstat-Dx BCID GPF Plus AMR Panel, its first QIAstat-Dx bloodstream infection panel cleared for the U.S. market. The panel detects 20 gram-positive bacterial and fungal pathogen targets, a broad pan gram-negative target and 10 antimicrobial resistance markers from positive blood cultures in about one hour. The clearance expands QIAGEN’s U.S. syndromic testing portfolio into bloodstream infection diagnostics, joining respiratory, gastrointestinal and central nervous system testing on the QIAstat-Dx platform. QIAGEN said the test can support faster clinical decision-making, antimicrobial stewardship and infection prevention, particularly because bloodstream infections can rapidly progress to sepsis.

(PRESS RELEASE) VENLO, 11-Aug-2026 — /EuropaWire/ — QIAGEN has received clearance from the U.S. Food and Drug Administration for the QIAstat-Dx BCID GPF Plus AMR Panel, marking the first QIAstat-Dx bloodstream infection panel to secure FDA clearance.

The clearance expands QIAGEN’s U.S. syndromic testing portfolio into bloodstream infection diagnostics.

It also establishes the first product in a planned family of QIAstat-Dx BCID panels for the U.S. market.

The QIAstat-Dx platform is now used across four major infectious disease areas: respiratory infections, gastrointestinal infections, central nervous system infections and bloodstream infections.

The platform is available in more than 100 countries and had reached more than 5,200 cumulative placements by the end of 2025.

The newly cleared QIAstat-Dx BCID GPF Plus AMR Panel detects 20 gram-positive bacterial and fungal pathogen targets, a broad pan gram-negative target and 10 genetic antimicrobial resistance markers from positive blood culture samples.

The test provides results in about one hour.

QIAGEN said the rapid identification of pathogens and antimicrobial resistance gene markers can support more informed treatment decisions, antimicrobial stewardship and infection prevention measures.

Bloodstream infections are linked to significant illness and mortality and can progress rapidly to sepsis, a life-threatening reaction to infection in which the immune system damages healthy tissues and organs.

An estimated 1.7 million adults develop sepsis each year in the United States, underlining the need for timely diagnostic information in clinical settings.

Nitin Sood, Senior Vice President and Head of Product Portfolio & Innovation at QIAGEN, said every hour, and even minutes, matter when dealing with bloodstream infections.

He said the FDA clearance gives U.S. laboratories a fast and integrated method for identifying pathogens and key genetic antimicrobial resistance markers.

Sood added that the panel can support better-informed treatment decisions and responsible antibiotic use.

He also said the clearance establishes the first member of a broader QIAstat-Dx bloodstream infection panel family planned for the U.S.

The QIAstat-Dx system integrates sample preparation, multiplex PCR testing and data analysis into a single workflow.

It is designed to deliver rapid results that are easy to interpret while reducing hands-on time for laboratory professionals.

The FDA clearance also provides a foundation for QIAGEN to continue expanding its bloodstream infection testing portfolio in the United States.

A complementary QIAstat-Dx BCID GN Plus AMR Panel, designed to detect gram-negative pathogens and associated genetic antimicrobial resistance markers, is currently under FDA review.

QIAGEN has continued to expand the QIAstat-Dx menu for the U.S. market.

The current portfolio includes the QIAstat-Dx Respiratory Panel Plus, QIAstat-Dx Respiratory Panel Mini, QIAstat-Dx Gastrointestinal Panel 2, QIAstat-Dx GI Panel 2 Mini B, QIAstat-Dx GI Panel 2 Mini B&V, QIAstat-Dx Meningitis/Encephalitis Panel and the newly cleared QIAstat-Dx BCID GPF Plus AMR Panel.

The company said this expansion reflects its strategy of building a comprehensive infectious disease testing menu on a single integrated syndromic testing platform.

With the FDA clearance of its first bloodstream infection panel, QIAGEN is strengthening its position in rapid molecular diagnostics and extending the clinical utility of the QIAstat-Dx platform for laboratories managing urgent infectious disease cases.

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is a global leader in Sample to Insight solutions that enable customers to extract and analyze molecular information from biological samples containing the building blocks of life. Our Sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies prepare these biomolecules for analysis, while bioinformatics support the interpretation of complex data to deliver actionable insights. Automation solutions integrate these steps into streamlined, cost-effective workflows. QIAGEN serves more than 500,000 customers worldwide in the Life Sciences (academia, pharmaceutical R&D and industrial applications such as forensics) and Molecular Diagnostics (clinical healthcare). As of June 30, 2026, QIAGEN employed about 5,500 people across more than 35 locations. For more information, visit www.qiagen.com.

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1 Centers for Disease Control and Prevention (CDC). About Sepsis. Available at: https://www.cdc.gov/sepsis/about/index.html (accessed August 2026).

Media Contact:

John Gilardi
Vice President
Head of Corporate Communications
Global
Germany: +49 2103 29 11711
Mobile: +49 152 018 11711
john.gilardi@qiagen.com

SOURCE: QIAGEN