As reported on PharmaBiz, Qiagen has received US Food and Drug Administration (FDA) clearance for its QIAstat-Dx BCID GPF Plus AMR Panel, marking the company’s entry into the US bloodstream infection diagnostics market and expanding the capabilities of its QIAstat-Dx syndromic testing platform.
The newly cleared test is designed to identify bloodstream infections from positive blood culture samples in approximately one hour. It can detect 20 gram-positive bacterial and fungal pathogens, a broad gram-negative target, and 10 genetic markers associated with antimicrobial resistance. By providing rapid information on both the infectious organism and potential drug resistance, the panel aims to help clinicians make faster treatment decisions and support antimicrobial stewardship initiatives.
Bloodstream infections remain a major clinical challenge because they can quickly progress to sepsis, a severe and potentially fatal condition caused by the body’s overwhelming response to infection. With roughly 1.7 million adults in the United States affected by sepsis each year, timely pathogen identification is critical for improving patient outcomes.
According to Qiagen, the QIAstat-Dx system combines sample preparation, multiplex PCR testing, and data analysis within a single workflow, reducing laboratory hands-on time while delivering clear and actionable results. Company executives emphasized that rapid detection is particularly important in bloodstream infections, where treatment delays can significantly affect outcomes.
The FDA authorization represents the first member of a planned family of bloodstream infection panels for the QIAstat-Dx platform in the US. Qiagen also revealed that a complementary BCID GN Plus AMR Panel, focused on gram-negative pathogens and related resistance markers, is currently undergoing FDA review.
The clearance broadens Qiagen’s infectious disease testing portfolio, adding bloodstream infections to existing menu offerings covering respiratory, gastrointestinal, and central nervous system diseases. The QIAstat-Dx platform is available in more than 100 countries and had surpassed 5,200 cumulative placements worldwide by the end of 2025.
Qiagen continues to position QIAstat-Dx as a comprehensive molecular diagnostics platform, offering laboratories access to multiple infectious disease assays through a single integrated system. The company serves more than 500,000 customers globally across life sciences and molecular diagnostics markets and employs approximately 5,500 people at over 35 locations worldwide.
