Affinity Biosensors, an innovator in the field of healthcare diagnostics, has declared that its groundbreaking LifeScale AST system has received FDA clearance.

This milestone gives healthcare professionals an important tool for managing bacteremia by providing antibiotic susceptibility test (AST) results with unprecedented speed.

The LifeScale AST system is a state-of-the-art diagnostic platform that uses advanced technology to rapidly assess key antibiotics to determine which will be most effective in the treatment of dangerous bloodstream infections. LifeScale AST will empower healthcare providers to make informed decisions that will improve patient outcomes, reduce the duration and cost of treatment, and support antibiotic stewardship.

Dr. Ken Babcock, CEO of Affinity Biosensors, said, "We are very proud of achieving FDA clearance for the LifeScale AST system. This revolutionary technology has the potential to transform how infections associated with sepsis are treated. We are very grateful to our dedicated team and partners who have worked tirelessly to bring LifeScale AST to market. We are especially gratified to witness this performance borne out in our collaborations with healthcare institutions nationwide."

LifeScale AST is an automated benchtop system that performs rapid phenotypic antibiotic susceptibility tests (ASTs). In addition to its unparalleled speed, LifeScale AST is designed to fit seamlessly into existing clinical workflows, and features simple, chemistry-free sample preparation and processing, high throughput and cost-effective operation, convenient room-temperature consumables storage, and compatibility with existing organism identification systems.

The touchscreen-driven automated workflow requires minimal hands-on time by the technologist. Minimum inhibitory concentration (MIC) results are reported as well as interpretive (SIR) results using CLSI or FDA breakpoints. Multiple samples can be processed on this bench-top instrument.