Selux Diagnostics, a biotech startup in Boston whose mission is to combat superbug infections and antimicrobial resistance (AMR), has received its second 510(k) clearance on the Selux Next Generation Phenotyping (NGP) System from the U.S. Food and Drug Administration (FDA) for its proprietary NGP Gram-Negative Panel. The newly approved panel, intended for use with isolated colonies, adds 23 gram-negative antimicrobial agents to the rapid antibiotic susceptibility testing (AST) platform, a critical diagnostic test that informs personalized antibiotic therapy. The Selux NGP System was first cleared by the FDA in January 2023 along with the Selux NGP Gram-Positive Panel. 

With the addition of the Gram-Negative Panel to the Selux NGP System, Selux now offers an extremely comprehensive AST single panel. The Selux NGP Gram-Negative Panel provides results for twice as many antibiotics per patient sample as legacy AST systems, according to the company. By combining results for commonly used generic antibiotics with recently approved drugs capable of treating multi-drug resistant (MDR) infections, such as Vabomere and Avycaz, the NGP Gram-Negative Panel enables clinicians to rapidly provide MDR-infected patients with personalized therapies crucial for survival. 

The NGP System FDA clearances also include a Breakpoint Change Protocol developed with FDA to allow Selux to rapidly update breakpoints, critical for ensuring Selux NGP customers have up-to-date results that meet College of American Pathologists (CAP) requirements.

“The clearance of our Gram-Negative panel brings us one step closer to combating the surge in antibiotic resistant superbugs,” says Steve Lufkin, CEO of Selux Diagnostics. “As bacteria are becoming more resistant to antibiotics, laboratories need an AST platform that can keep pace with current breakpoints and room to grow as new drugs come on the market. The ability to receive same-shift results combined with a comprehensive antibiotic menu should save lives, shorten hospital stays, and combat antimicrobial resistance.” 

Without a significant change in today’s treatment options, experts predict that deaths from superbugs will surpass deaths from cancer by 2050. Selux is working to address this global health crisis by improving the speed and performance of AST.