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PRESS RELEASE: FDA Clears Affinity Biosensor Analyzer for Bacteremia Treatment Guidance

Image created by Dr. Michael J. Miller

Affinity Biosensors said on Wednesday that the firm has received US Food and Drug Administration 510(k) marketing clearance for its benchtop analyzer that is used to guide the treatment of bacteremia.

The Santa Barbara, California-based firm said that its LifeScale AST analyzer uses a microfluidic sensor to measure the masses of thousands of bacteria and perform rapid phenotypic antibiotic susceptibility tests. Results returned include the identification of carbapenem-resistant and multi-drug resistant organisms. The automated instrument produces a population profile that can help clinicians determine which antibiotics are the most likely to be effective against a bloodstream infection, with results within five hours.

"This revolutionary technology has the potential to transform how infections associated with sepsis are treated," Affinity CEO Ken Babcock said in a statement.

The company said that the system uses chemistry-free sample preparation and processing, cost-effective high-throughput operation, room-temperature consumables storage, and compatibility with existing microorganism identification systems. It generates minimum inhibitory concentration results and interpretive results that use breakpoints from the Clinical and Laboratory Standards Institute and the FDA.

The firm said that it has developed with the instrument an initial Gram-negative blood culture antibiotic susceptibility testing panel, and additional tests are planned.

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