Affinity Biosensors, a leader in rapid phenotypic antimicrobial susceptibility diagnostics, proudly announces that the U.S. Food and Drug Administration (FDA) has granted its third clearance for the LifeScale AST system. This latest clearance extends the system’s capabilities to include a broader range of less-prevalent organisms, enabling hospitals and clinical laboratories to bring rapid, actionable susceptibility testing to previously underserved pathogen subsets.
“This third clearance reflects our commitment to advancing rapid phenotypic AST and responding to the evolving needs of antimicrobial stewardship,” said Dr. Ken Babcock, CEO of Affinity Biosensors. “By bringing LifeScale into new organism territories, we’re helping labs get answers faster — even for rarer blood-stream pathogens — and enabling clinicians to act with greater confidence.”