Selux Diagnostics Receives FDA Green Light for Positive Blood Culture Separator

Selux Diagnostics, a Boston-based biotechnology startup, announced that it has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) for its Positive Blood Culture Separator ( PBC). This technology integrates into Selux's Next Generation Phenotyping (NGP) System, making it the only platform capable of rapidly providing antimicrobial susceptibility testing (AST) results from positive blood cultures and colonies. isolated.

The authorization granted to the Selux PBC Separator allows testing directly from a positive blood culture, without requiring subculture. This significant advance allows the determination of bacterial sensitivity to 17 specific antibiotic agents. Additionally, this technology received a breakthrough designation from the FDA, highlighting its potential to address a critical need in the field of AST.

Steve Lufkin, CEO of Selux Diagnostics, expressed his gratitude to the teams and partners who contributed to this achievement. Infectious disease specialist James S. Lewis II welcomed the breakthrough as a significant leap in the fight against difficult-to-treat infections.

This achievement marks an important development in the care of infectious diseases, promising targeted therapeutic test results more quickly than current methods.