Affinity Biosensors Receives FDA Clearance for the LifeScale AST System

SANTA BARBARA, Calif., April 3, 2024 /PRNewswire/ -- 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:

1. 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.
2. 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.
3. 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.”

To learn more about Affinity Biosensors and the LifeScale AST system, please visit https://affinitybio.com.

About LifeScale

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.

The system employs unique microfluidic sensing that measures the masses of individual microbes at high throughput, enabling the fastest possible assessment of phenotypic response to antibiotics and accurate results for carbapenem-resistant and multi-drug resistant organisms. Additional AST tests are planned to follow the initial Gram-negative blood culture AST panel.

About Affinity Biosensors

Affinity Biosensors was founded in 2006 to develop advanced instrumentation for life science and diagnostic applications. Since 2014 the company has focused on advancing its core mass-sensing technology to address the global challenges posed by multi-drug resistant infections. The LifeScale AST system was designed as an easily extensible rapid phenotypic AST platform that will address a wide range of AST needs, allowing the clinician to determine targeted therapy with unparalleled speed.

Contact for Media and Customers:

George Goedesky

Affinity Biosensors