Boston-based Selux Diagnostics, Inc., a diagnostics firm that combats superbug infections and fights antibiotic resistance, has announced its Next Generation Phenotyping (NGP) platform received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for positive blood culture and sterile body fluid samples.
“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,” says 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.”
Selux NGP is a single-platform technology capable of delivering rapid AST results across all sample types with an 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 FDA created the Breakthrough Devices Program to provide patients and providers with timely access to medical devices by speeding up their development, assessment, and review process while preserving statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization. The designated device must provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating human disease or condition.
In addition, Breakthrough Designation may provide reimbursement benefit, subject to ongoing CMS consideration of the proposed Medicare Coverage of Innovative Technology (MCIT) program.
“Today’s delay of as much as four-plus 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,” Lufkin says. “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.”
The Selux platform is an investigational device, limited by federal law to investigational use.