Medical Device Network

FDA clears Affinity Biosensors’s LifeScale AST diagnostic platform

The development can enhance the management of bacteremia by delivering AST results with unprecedented speed.

The US Food and Drug Administration (FDA) has granted clearance for Affinity Biosensors’s LifeScale AST system, a diagnostic tool for rapid antibiotic susceptibility testing (AST).

This development promises to enhance the management of bacteremia by delivering AST results with unprecedented speed.

The clearance of LifeScale AST system provides clinicians with a critical resource for combating bloodstream infections.

The system's ability to rapidly identify the most effective antibiotics for treatment can improve patient care, reduce healthcare costs, and promote responsible use of antibiotics.

It is claimed to stand out for its rapid results, delivering AST outcomes in under five hours.

This is a substantial improvement over traditional methods, enabling faster decision-making in the selection of antibiotic therapies.

Its comprehensive testing includes a range of antibiotics, with a focus on those that combat multi-drug resistant bacteria.

Affinity Biosensors has incorporated advanced technology into the LifeScale AST system, utilising population profiling through microfluidic sensors.

These sensors measure the mass of thousands of individual bacteria, ensuring high accuracy in the AST results. This approach can support in maintaining the reliability of the diagnostics provided by the system.

The design of the LifeScale AST system also prioritises ease of use, with a user-friendly interface and automated processes that streamline laboratory workflows.

This allows healthcare professionals to devote more attention to patient care, optimising the overall treatment process.

Affinity Biosensors CEO Dr Ken Babcock 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.”