By IDSE News Staff

The FDA granted 510(k) clearance to the Next Generation Phenotyping (NGP) System (Selux Diagnostics), a rapid antibiotic susceptibility testing (AST) platform that provides targeted therapeutic results days faster than the current standard of care.

The agency cleared the system’s in vitro antimicrobial resistance (AMR) test, which can determine bacteria’s susceptibility to 14 specific antimicrobial agents on the Selux gram-positive panel. The FDA is still reviewing the gram-negative panel. Selux NGP is capable of delivering quick AST results across all sample types. In addition, this technology is able to deliver phenotypic AST from both positive blood bottles and isolated colonies, thus providing actionable results that may indicate more effective therapies to treat individuals’ infections, according to the company.

In 2021, the FDA granted a breakthrough device designation to the NGP platform for positive blood culture and sterile body fluid samples. Afterward, the company was awarded $2.8 million from the National Institutes of Health to assist in the commercialization of the platform for rapid AST.

Unless action is taken, rates of resistance will continue to rise, and deaths from AMR and superbugs, like methicillin-resistant Staphylococcus aureus, could reach 10 million annually by 2050 (Tackling drug-resistant infections globally: final report and recommendations. May 19, 2016.).

“We have been waiting for true innovation in AST technologies to deliver rapid results that are accurate according to the latest FDA guidelines and include newly approved antibiotics,” said James S. Lewis II, PharmD, FIDSA, the co-director of antibiotic stewardship at Oregon Health and Science University, in Portland, and chair of the Clinical and Laboratory Standards Institute Antimicrobial Susceptibility Testing Subcommittee. 

“I am enthusiastic that the Selux NGP System addresses these critical needs and will become an essential tool for directing personalized therapies for infected patients,” Dr. Lewis said in a company release.

—From company press materials