Breakthrough device designation for AST platform

Oct. 4, 2021

The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation for a next generation phenotyping platform using positive blood culture and sterile body fluid samples from Selux Diagnostics, according to a news release from the company.

The Selux platform provides rapid antibiotic susceptibility testing (AST) to help prevent antibiotic resistance by matching patients with the right drugs to fight infections. 

With the breakthrough designation, Selux will focus on clinical trials.

Selux NGP is a single-platform technology capable of delivering rapid AST results across all sample types. In addition to positive blood culture and sterile body fluid samples, the NGP technology from Selux delivers phenotypic AST from isolated colonies, which is not part of the FDA breakthrough devices program.

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 Selux platform is an investigational device, limited by federal law to investigational use.

Visit Selux for more news