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Groundbreaking Diagnostic Platform Provides AST Results With Unprecedented Speed

By LabMedica International staff writers
Posted on 05 Apr 2024
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Image: The LifeScale AST automated benchtop system has received U.S. FDA clearance (Photo courtesy of Affinity Biosensors)
Image: The LifeScale AST automated benchtop system has received U.S. FDA clearance (Photo courtesy of Affinity Biosensors)

A groundbreaking diagnostic platform that delivers antibiotic susceptibility test (AST) results with unprecedented speed can become an important tool for healthcare professionals to manage bacteremia.

The LifeScale AST system from Affinity Biosensors (Santa Barbara, CA, USA) is a state-of-the-art diagnostic platform that rapidly identifies the most effective antibiotics for treating dangerous bloodstream infections. This revolutionary system enables healthcare professionals to make well-informed treatment decisions, enhancing patient recovery, minimizing treatment costs, and promoting responsible antibiotic use. The fully automated benchtop system utilizes unique microfluidic sensing to measure the masses of individual microbes at high throughput, facilitating rapid and precise evaluation of phenotypic response to antibiotics. It delivers accurate results for carbapenem-resistant and multi-drug-resistant organisms in less than five hours—substantially reducing the time required for selecting the most appropriate antibiotic therapies for patients.

Designed to fit seamlessly into existing clinical workflows, LifeScale AST features simple, chemistry-free sample preparation and processing, high throughput, and cost-effective operations. It also boasts room-temperature consumables storage and compatibility with existing organism identification systems. The system's user-friendly touchscreen interface automates the workflow, significantly reducing the minimal hands-on time required for technicians. It provides minimum inhibitory concentration (MIC) results as well as interpretive (SIR) results using CLSI or FDA breakpoints. The capability to process multiple samples simultaneously further enhances the system's utility in a clinical setting. Following the initial launch of the Gram-negative blood culture AST panel plans for additional AST tests are underway. The LifeScale AST system has now received clearance from the U.S. Food and Drug Administration (FDA).

"We are very proud of achieving FDA clearance for the LifeScale AST system,” said Dr. Ken Babcock, CEO of Affinity Biosensors. “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."

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