QIAGEN Completes U.S. QIAstat-Dx Bloodstream Infection Portfolio With FDA Clearance of New Bacteria Detection Panel

• Bloodstream infections can trigger sepsis, a life-threatening response to infection; about 1.7 million U.S. adults develop sepsis each year, contributing to at least 350,000 deaths

• New QIAstat-Dx test identifies 13 gram-negative bacterial targets and 18 antibiotic resistance markers in about one hour

• Complete QIAstat-Dx bloodstream infection menu combines two complementary panels and covers 33 pathogen targets and 28 antibiotic resistance markers

GERMANTOWN, Md. & VENLO, Netherlands--(BUSINESS WIRE)--QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that U.S. laboratories now have access to the complete QIAstat-Dx bloodstream infection portfolio following clearance of a new panel by the U.S. Food and Drug Administration (FDA).

The new panel detects gram-negative bacteria and antibiotic resistance markers in about one hour, complementing the recently FDA-cleared QIAstat-Dx panel for gram-positive bacteria and fungi.

Bloodstream infections can become serious very quickly and can trigger sepsis, a life-threatening response to infection that can lead to organ failure and death. According to the U.S. Centers for Disease Control and Prevention, about 1.7 million adults in the U.S. develop sepsis each year, and at least 350,000 die during hospitalization or are discharged to hospice. Faster identification of what is causing an infection can provide clinicians with important information to guide treatment decisions.

The new QIAstat-Dx BCID GN Plus AMR Panel identifies 13 gram-negative bacterial pathogen targets and 18 antimicrobial resistance markers. It complements the recently cleared QIAstat-Dx BCID GPF Plus AMR Panel, which identifies gram-positive bacteria and fungi.

Together, the two panels cover 33 pathogen targets and 28 antimicrobial resistance markers. The gram-negative panel covers 13 pathogen targets and 18 resistance markers, while the gram-positive and fungal panel covers 20 pathogen targets and 10 resistance markers. Both deliver results in about one hour.

The clearance also expands the QIAstat-Dx infectious disease testing menu in the U.S., which already includes tests for respiratory and gastrointestinal infections, as well as for meningitis and encephalitis.

“Bloodstream infections demand fast answers,” said Nitin Sood, Senior Vice President and Head of Product Portfolio & Innovation at QIAGEN. “With both panels now cleared in the U.S., laboratories can identify a broad range of pathogens and antibiotic resistance markers on the same QIAstat-Dx system. This can provide clinicians with timely information to support treatment decisions and address antibiotic resistance.”

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

For more information about QIAstat-Dx, visit https://www.qiagen.com/applications/syndromic-testing.

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.

Forward-Looking Statements

Certain statements in this press release may constitute forward-looking statements within the meaning of the U.S. federal securities laws. These statements include, among others, statements regarding QIAGEN’s products, product development and launches, regulatory approvals, market opportunities and future business performance. Forward-looking statements are based on current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially. These risks include, among others, the development and commercial success of new products, regulatory approvals, competition, changes in customer demand and funding, economic and market conditions, supply chain disruptions, cybersecurity incidents, litigation and other risks described under “Risk Factors” in QIAGEN’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. QIAGEN undertakes no obligation to update any forward-looking statement except as required by law.

Source: QIAGEN N.V.

Category: Infectious Diseases