The US Food and Drug Administration (FDA) has granted 510(k) clearance to Boston-based biotech startup SeLux Diagnostics’s Next Generation Phenotyping (NGP) System for rapid antibiotic susceptibility (AST) testing.
The testing platform aims to allow clinical labs to provide targeted therapeutic results days quicker than the present standard of care.
The regulatory approval is for the company’s in vitro antimicrobial resistance test, which ascertains the susceptibility of a bacteria to 14 particular antimicrobial agents on the Selux Gram-Positive Panel.
Currently, the US FDA is reviewing the company’s NGP Gram-Negative panel.
Selux Diagnostics CEO Steve Lufkin said: “This clearance represents a significant advance in infectious disease care and the fight to address antibiotic resistance. Our groundbreaking Selux NGP System holds the potential to save lives and decrease overreliance on broad-spectrum antibiotics, a key factor contributing to the rise of superbugs.”
Clinical and Laboratory Standards Institute (CLSI) Antimicrobial Susceptibility Testing Subcommittee chair and Oregon Health and Science University co-director of antibiotic stewardship James S Lewis II said: “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. I am enthusiastic that the Selux NGP System addresses these critical needs and will become an essential tool for directing personalised therapies for infected patients.”
Experts believe that deaths caused by superbugs will surpass deaths due to cancer by 2050 unless there is a huge change in the treatment options.
Selux stated that it is dealing with this health crisis by working on the speed and performance of AST, which is a critical diagnostic test for informed personalised antibiotic treatment.
The platform has been either completely or partially backed by federal funds from the US Department of Health and Human Services (HHS), the Administration for Strategic Preparedness and Response (ASPR), and the Biomedical Advanced Research and Development Authority (BARDA).