Image created by Dr. Michael J. Miller
QIAGEN N.V. headquartered in Venlo, Netherlands with a major U.S. base in Germantown, Maryland, announced that U.S. laboratories now have access to its complete QIAstat-Dx bloodstream infection portfolio, following FDA clearance of a new panel that detects gram-negative bacteria and antibiotic resistance markers in about one hour. The new QIAstat-Dx BCID GN Plus AMR Panel identifies 13 gram-negative bacterial pathogen targets and 18 antimicrobial resistance markers, complementing the recently cleared QIAstat-Dx BCID GPF Plus AMR Panel for gram-positive bacteria and fungi (which covers 20 pathogen targets and 10 resistance markers). Together, the two panels cover 33 pathogen targets and 28 antimicrobial resistance markers, both delivering results in about an hour.
Nitin Sood, Senior Vice President and Head of Product Portfolio & Innovation at QIAGEN, said: “Bloodstream infections demand fast answers. 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.”
Why Speed Matters With Sepsis
Bloodstream infections can escalate quickly into sepsis, a life-threatening response to infection that can lead to organ failure and death. According to the CDC, roughly 1.7 million U.S. adults develop sepsis each year, and at least 350,000 die during hospitalization or are discharged to hospice. Faster identification of the pathogen behind an infection gives clinicians critical information to guide treatment. The new clearance also extends QIAGEN’s U.S. QIAstat-Dx infectious disease menu — which already covers respiratory and gastrointestinal infections, plus meningitis and encephalitis — into a fourth major disease category: bloodstream infections.
How the System Works
QIAstat-Dx combines sample preparation, multiplex PCR testing, and data analysis into a single automated workflow. The platform is available in more than 100 countries, with more than 5,200 cumulative placements as of the end of 2025.