- In April 2025, DiaSorin revealed that it had obtained FDA 510(k) clearance for its Liaison Plex Gram-Negative Blood Culture Assay, the second of three multiplex molecular panels intended for pathogen identification in blood cultures on the Liaison Plex platform. This assay detects 27 pathogens, including 19 gram-negative bacteria and eight key resistance gene targets, such as Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, among others.
- In March 2025, Accelerate Diagnostics submitted its WAVE System and gram-negative test kit for FDA 510(k) clearance. The system delivers rapid antimicrobial susceptibility testing (AST) results in ~4.5 hours directly from blood cultures, enabling same-shift targeted therapy. This addresses sepsis (49 million annual cases, 11 million deaths) and antimicrobial resistance (1.32 million annual deaths), potentially reducing healthcare costs ($62 billion/year U.S. sepsis burden). The WAVE complements existing FDA-cleared solutions like the Pheno system (7-hour AST) and Arc system (automated sample prep), enhancing lab efficiency and patient outcomes.
- In February 2025, Biogenix Inc. Pvt. Ltd. introduced the Bugz32, a fully automated blood culture instrument with a 32-position capacity, aimed at microbiology labs. Designed to deliver fast, accurate, and reliable results, the Bugz32 is part of the company's broader portfolio of diagnostic instruments and kits.
- In November 2024, Copan introduced HEMO, an automated system created to optimize the processing of positive blood cultures by automating sample transfer and tracking.
