Next Generation Rapid Antibiotic Susceptibility Testing (AST) Platform Granted FDA Breakthrough Device Designation

By LabMedica International staff writers
Posted on 05 Oct 2021

Image: Next Generation Phenotyping Platform from Selux (Photo courtesy of Selux Diagnostics, Inc.)

Selux Diagnostics, Inc.’s (Boston, MA, USA) Next Generation Phenotyping (NGP) platform has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for positive blood culture and sterile body fluid samples.

Selux NGP is the only single-platform technology capable of delivering rapid AST results across all sample types with an unprecedented antibiotic menu. Selux's NGP technology delivers phenotypic AST from both Positive Blood Bottles and isolated colonies - which may provide actionable results to indicate which therapies may effectively treat a patient's infection. The proprietary Selux technology uniquely provides targeted therapy results days faster than the current standard of care providing actionable information to inform patient treatment for all Infectious Diseases. Selux's NGP platform provides unprecedented speed-to-results and breadth of menu while meeting the accuracy, throughput, and cost effectiveness requirements of clinical microbiology laboratories and integrated healthcare systems.

"While currently under review for our rapid antimicrobial susceptibility test (AST) system for isolated bacterial colonies, the FDA recognized the urgent need to perform AST directly from blood and other sterile body fluids by granting us Breakthrough Designation," said Steve Lufkin, CEO of Selux. "The NGP technology is uniquely positioned to accelerate personalized therapy selection for patients while leading the fight against antibiotic resistance. We are honored by the FDA recognition of the Selux platform for these sample types."

"Today's delay of as much as 4+ days before AST results are available for the sickest patients is not optimal. The Selux platform is capable of testing up to 40 drugs in parallel, with room to expand as new therapies become available," added Lufkin "Providing more rapid results for patients with drug resistant infections may allow Physicians to prescribe targeted antimicrobial therapy much sooner, reducing hospital length of stays and help combat drug resistance."

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Selux Diagnostics, Inc.