Qiagen Wins FDA Clearance for Bloodstream Infection Test
By Anvee Bhutani
Qiagen said Monday that the U.S. Food and Drug Administration cleared its first QIAstat-Dx test for bloodstream infections, expanding the diagnostics company's infectious-disease testing portfolio in the U.S.
The QIAstat-Dx BCID GPF Plus AMR Panel can detect 20 pathogen targets and 10 genetic antimicrobial-resistance markers from positive blood cultures in about an hour, Qiagen said.
The test is designed to help clinicians identify infections and resistance markers more quickly, potentially supporting treatment decisions and antibiotic stewardship. Bloodstream infections can rapidly progress to sepsis, a life-threatening condition that affects an estimated 1.7 million U.S. adults annually, the company said.
The FDA clearance marks Qiagen's entry into U.S. bloodstream-infection testing and the first of a planned family of QIAstat-Dx bloodstream-infection panels. A complementary panel focused on gram-negative pathogens and resistance markers is under FDA review, the company said.
Qiagen's QIAstat-Dx platform, which integrates sample preparation, multiplex PCR testing and data analysis, is available in more than 100 countries.
Write to Anvee Bhutani at anvee.bhutani@wsj.com
(END) Dow Jones Newswires
August 10, 2026 17:46 ET (21:46 GMT)
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