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FDA Grants Clearance to Affinity Biosensors for LifeScale AST System

Thursday, April 04, 2024

Affinity Biosensors, a leading innovator in healthcare diagnostics, proudly announces the FDA clearance for its groundbreaking LifeScale AST system. This achievement marks a significant milestone in advancing bacteremia management by offering healthcare professionals rapid antibiotic susceptibility test (AST) results.

The LifeScale AST system is a state-of-the-art diagnostic platform designed to swiftly evaluate key antibiotics, aiding in the selection of the most effective treatment for bloodstream infections. It provides results in under 5 hours, significantly reducing the time needed to determine appropriate antibiotic therapy. Moreover, the system maintains high accuracy standards through its unique population profiling technology.

LifeScale AST streamlines laboratory operations with its user-friendly interface and automated processes, allowing healthcare professionals to focus on patient care. This innovative technology has the potential to improve patient outcomes, reduce treatment duration and costs, and support antibiotic stewardship efforts.

Affinity Biosensors extends gratitude to its dedicated team and partners for their contributions to bringing LifeScale AST to market. Collaboration with healthcare institutions nationwide has been instrumental in validating the performance and impact of this system.

LifeScale AST is an automated benchtop system that performs rapid phenotypic antibiotic susceptibility tests. Its features include simple sample preparation, high throughput, and compatibility with existing organism identification systems. The system's touchscreen-driven workflow minimizes technologist intervention while providing both minimum inhibitory concentration (MIC) and interpretive results.

With plans to expand AST tests beyond the initial Gram-negative blood culture panel, LifeScale AST aims to further enhance its capabilities in addressing antibiotic resistance and improving patient care.






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