GERMANTOWN, Md. and VENLO, Netherlands — September 28, 2026

QIAGEN N.V. announced that the U.S. Food and Drug Administration has cleared the QIAstat-Dx BCID GN Plus AMR Panel, completing the company’s QIAstat-Dx bloodstream infection testing portfolio in the United States. The new molecular diagnostic panel detects 13 gram-negative bacterial pathogen targets and 18 antimicrobial resistance markers and delivers results in approximately one hour. The panel complements the previously FDA-cleared QIAstat-Dx BCID GPF Plus AMR Panel, which detects gram-positive bacteria and fungi. Together, the two panels cover 33 pathogen targets and 28 antibiotic resistance markers on the QIAstat-Dx system.

New Panel Detects Gram-Negative Pathogens and Resistance Markers

The QIAstat-Dx BCID GN Plus AMR Panel is designed to provide rapid molecular information on gram-negative bacteria and selected antimicrobial resistance markers in bloodstream infections. The panel uses the QIAstat-Dx automated workflow, which integrates sample preparation, multiplex polymerase chain reaction (PCR) testing and data analysis. The complementary BCID GPF Plus AMR Panel covers 20 pathogen targets and 10 resistance markers associated with gram-positive bacteria and fungi. By combining the two panels, U.S. laboratories can access broader bloodstream infection testing capabilities through the QIAstat-Dx platform while receiving results in about one hour.

QIAstat-Dx Portfolio Expands U.S. Infectious Disease Testing

The FDA clearance expands the QIAstat-Dx infectious disease testing menu available to U.S. laboratories. In addition to bloodstream infection panels, the platform includes molecular tests addressing respiratory and gastrointestinal infections as well as meningitis and encephalitis. QIAGEN said the QIAstat-Dx system is available in more than 100 countries, with more than 5,200 cumulative placements as of the end of 2025. The company is positioning the expanded bloodstream infection portfolio as a tool that can provide laboratories with timely pathogen and antimicrobial resistance information that may support clinical treatment decisions.

Advertisement

cGxPJobs Banner

QIAGEN Addresses Rapid Bloodstream Infection Testing Needs

Bloodstream infections can progress to sepsis, making rapid identification of infectious pathogens an important component of clinical evaluation. QIAGEN cited U.S. Centers for Disease Control and Prevention estimates that approximately 1.7 million U.S. adults develop sepsis each year, with at least 350,000 dying during hospitalization or being discharged to hospice. The company said faster identification of causative pathogens and resistance markers can provide clinicians with information relevant to treatment decisions, although molecular detection results are intended to be interpreted in conjunction with other clinical and laboratory findings. The new FDA clearance gives U.S. laboratories access to the complete QIAstat-Dx bloodstream infection portfolio and broadens the platform’s role in syndromic molecular diagnostics.

Source QIAGEN press release