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QIAGEN Receives U.S. FDA Clearance for First QIAstat-Dx Bloodstream Infection Panel

QGEN
  • FDA cleared the QIAstat-Dx BCID GPF Plus AMR Panel, marking QIAGEN's entry into U.S. bloodstream infection testing.
  • The panel detects 20 gram-positive bacterial & fungal pathogen targets, a broad pan gram-negative target, & 10 antimicrobial resistance markers from positive blood cultures in approximately one hour.
  • This clearance expands QIAGEN's U.S. syndromic testing portfolio into bloodstream infections, the fourth major infectious disease area covered by the QIAstat-Dx platform.
  • The QIAstat-Dx system integrates sample preparation, multiplex PCR testing, & data analysis into a single workflow to reduce hands-on time & support informed treatment decisions.
  • Bloodstream infections affect an estimated 1.7 million adults annually in the U.S., often progressing rapidly to sepsis.
  • A complementary QIAstat-Dx BCID GN Plus AMR Panel for gram-negative pathogens is currently under FDA review.
  • As of the end of 2025, the QIAstat-Dx platform was available in more than 100 countries with over 5,200 cumulative placements.
  • The U.S. portfolio now includes respiratory, gastrointestinal, central nervous system, & bloodstream infection panels on a single integrated platform.
  • QIAGEN employs about 5,500 people across more than 35 locations as of June 30, 2026.