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QIAGEN Expands US QIAstat-Dx Portfolio With New FDA-Cleared Panel
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Key Takeaways
QGEN's new panel detects 13 gram-negative pathogens and 18 antimicrobial resistance markers.
QIAGEN's two QIAstat-Dx panels cover 33 pathogen targets and 28 resistance markers in about one hour.
QGEN also launched QIAmini, its third new sample preparation system introduced in 2026.
QIAGEN N.V. (QGEN - Free Report) announced that U.S. laboratories now have access to its complete QIAstat-Dx bloodstream infection portfolio following FDA clearance of a new panel. The new QIAstat-Dx BCID GN Plus AMR Panel identifies 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.
The latest development expands the company’s QIAstat-Dx infectious disease testing menu in the United States, which already includes tests for respiratory and gastrointestinal infections, as well as meningitis and encephalitis.
Importance of QGEN’s New Bacteria Detection Panel
Bloodstream infections can progress rapidly and may lead to sepsis, a life-threatening response to infection that can result in organ failure and death. According to the U.S. Centers for Disease Control and Prevention, about 1.7 million adults in the United States develop sepsis each year, with at least 350,000 dying during hospitalization or being discharged to hospice. Faster identification of the cause of an infection can give clinicians important information to help guide treatment decisions.
The new Panel identifies 13 gram-negative bacterial pathogen targets and 18 antimicrobial resistance markers. More recently, QIAGEN earned FDA clearance for the QIAstat-Dx BCID GPF Plus AMR Panel, which detects 20 gram-positive bacterial and fungal pathogen targets as well as a broad pan-gram-negative target together with 10 genetic antimicrobial resistance markers from positive blood culture samples.
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.
More Developments Within QIAGEN
This month, QIAGEN announced the launch of QIAmini, a compact automated sample preparation system that offers research laboratories a time-saving and cost-efficient alternative to manual sample processing. It is the third new QIAGEN sample preparation system launched in 2026, following QIAsprint Connect for high-throughput research sample processing and QIAsymphony Connect for medium-throughput sample processing.
QGEN’s Industry Prospects
According to Fortune Business Insights, the bloodstream infection testing market was valued at $801 million in 2025 and is projected to witness a CAGR of 4.6% through 2034. The market is heavily influenced by rapid molecular diagnostics, automation in clinical microbiology, AI-assisted pathogen detection technologies, as well as the rising adoption of syndromic testing panels and real-time antimicrobial resistance monitoring systems.
Updates From QGEN Peers
Apart from QIAGEN, several key players in the bloodstream infection testing industry have recently made notable advancements.
Bruker (BRKR - Free Report) has introduced new timsUltra AIP and timsOmni workflows for deeper protein-sequence coverage, targeted validation, mobility-resolved glycopeptide characterization, structural proteomics and oligonucleotide analysis. The company made the announcement at the Human Proteome Organization World Congress 2026. This month, Bruker also received a multi-system order from the University of California, Berkeley for high-field Nuclear Magnetic Resonance (“NMR”) instrumentation at the Pines Magnetic Resonance Center, which exceeds $6 million. The investment will enhance access to next-generation NMR technologies, including 800 MHz–class instrumentation.
Becton, Dickinson and Company (BDX - Free Report) , or BD, announced that Fairview Health Services has become the first health system in the United States to deploy the BD Vmax 160, a next-generation pharmacy automation robot. The system is designed to help manage the growing complexity of specialty therapies and refrigerated medicines in high-volume, centralized outpatient pharmacies. BD’s STANCE clinical trial evaluating GalaFLEX LITE Scaffold in breast revision surgery for capsular contracture reached its first enrollment milestone, with 274 patients treated across 33 active U.S. sites.
Thermo Fisher Scientific (TMO - Free Report) recently launched the Gibco CHO-K1 Catalog Panel, a cGMP-ready portfolio of basal and feed media designed to support strong cell growth and protein production across CHO-K1 cell lines and is available in liquid and dry powder media formats. The company also introduced the Multiskan Ease Absorbance Microplate Reader to support protein quantification, enzyme-linked immunosorbent assays, cell viability studies, microbial growth monitoring and other routine laboratory applications with simplified operation and dependable performance. Thermo Fisher also announced the EMPAD G2 detector, designed to help researchers analyze materials in greater detail.
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QIAGEN Expands US QIAstat-Dx Portfolio With New FDA-Cleared Panel
Key Takeaways
QIAGEN N.V. (QGEN - Free Report) announced that U.S. laboratories now have access to its complete QIAstat-Dx bloodstream infection portfolio following FDA clearance of a new panel. The new QIAstat-Dx BCID GN Plus AMR Panel identifies 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.
The latest development expands the company’s QIAstat-Dx infectious disease testing menu in the United States, which already includes tests for respiratory and gastrointestinal infections, as well as meningitis and encephalitis.
Importance of QGEN’s New Bacteria Detection Panel
Bloodstream infections can progress rapidly and may lead to sepsis, a life-threatening response to infection that can result in organ failure and death. According to the U.S. Centers for Disease Control and Prevention, about 1.7 million adults in the United States develop sepsis each year, with at least 350,000 dying during hospitalization or being discharged to hospice. Faster identification of the cause of an infection can give clinicians important information to help guide treatment decisions.
The new Panel identifies 13 gram-negative bacterial pathogen targets and 18 antimicrobial resistance markers. More recently, QIAGEN earned FDA clearance for the QIAstat-Dx BCID GPF Plus AMR Panel, which detects 20 gram-positive bacterial and fungal pathogen targets as well as a broad pan-gram-negative target together with 10 genetic antimicrobial resistance markers from positive blood culture samples.
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.
More Developments Within QIAGEN
This month, QIAGEN announced the launch of QIAmini, a compact automated sample preparation system that offers research laboratories a time-saving and cost-efficient alternative to manual sample processing. It is the third new QIAGEN sample preparation system launched in 2026, following QIAsprint Connect for high-throughput research sample processing and QIAsymphony Connect for medium-throughput sample processing.
QGEN’s Industry Prospects
According to Fortune Business Insights, the bloodstream infection testing market was valued at $801 million in 2025 and is projected to witness a CAGR of 4.6% through 2034. The market is heavily influenced by rapid molecular diagnostics, automation in clinical microbiology, AI-assisted pathogen detection technologies, as well as the rising adoption of syndromic testing panels and real-time antimicrobial resistance monitoring systems.
Updates From QGEN Peers
Apart from QIAGEN, several key players in the bloodstream infection testing industry have recently made notable advancements.
Bruker (BRKR - Free Report) has introduced new timsUltra AIP and timsOmni workflows for deeper protein-sequence coverage, targeted validation, mobility-resolved glycopeptide characterization, structural proteomics and oligonucleotide analysis. The company made the announcement at the Human Proteome Organization World Congress 2026. This month, Bruker also received a multi-system order from the University of California, Berkeley for high-field Nuclear Magnetic Resonance (“NMR”) instrumentation at the Pines Magnetic Resonance Center, which exceeds $6 million. The investment will enhance access to next-generation NMR technologies, including 800 MHz–class instrumentation.
Becton, Dickinson and Company (BDX - Free Report) , or BD, announced that Fairview Health Services has become the first health system in the United States to deploy the BD Vmax 160, a next-generation pharmacy automation robot. The system is designed to help manage the growing complexity of specialty therapies and refrigerated medicines in high-volume, centralized outpatient pharmacies. BD’s STANCE clinical trial evaluating GalaFLEX LITE Scaffold in breast revision surgery for capsular contracture reached its first enrollment milestone, with 274 patients treated across 33 active U.S. sites.
Thermo Fisher Scientific (TMO - Free Report) recently launched the Gibco CHO-K1 Catalog Panel, a cGMP-ready portfolio of basal and feed media designed to support strong cell growth and protein production across CHO-K1 cell lines and is available in liquid and dry powder media formats. The company also introduced the Multiskan Ease Absorbance Microplate Reader to support protein quantification, enzyme-linked immunosorbent assays, cell viability studies, microbial growth monitoring and other routine laboratory applications with simplified operation and dependable performance. Thermo Fisher also announced the EMPAD G2 detector, designed to help researchers analyze materials in greater detail.