LifeScale AST system receives FDA Clearance

Affinity Biosensors, a leading innovator in the field of healthcare diagnostics, announces 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.

Key features of the LifeScale AST system include:

• Rapid results: LifeScale AST delivers results in under 5 hours, significantly reducing the time needed to select the most appropriate antibiotic therapy for patients.  The system tests a suite of antibiotics, including those targeting the most dangerous multi-drug resistant bacteria.
• High accuracy: LifeScale AST uses population profiling, in which a microfluidic sensor measures the masses of thousands of individual bacteria.  This unique technology enables fast AST results while maintaining high standards for accuracy.
• Streamlined workflow: LifeScale AST’s user-friendly interface and automated processes simplify laboratory operations, enabling healthcare professionals to focus on patient care.

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.”