Selux Diagnostics Receives FDA Clearance on Their Gram-Negative Panel, Expanding the Antibiotic Menu for Its Next Generation Phenotyping System for Rapid AST
Approval gives way to the most comprehensive single menu offered by an AST platform while delivering precise, rapid results in 5.5 hours from isolated colonies.
Boston, Mass, April 24, 2023 (Newswire.com) - Selux Diagnostics, a biotech startup in Boston whose mission is to combat superbug infections and antimicrobial resistance (AMR), announced it 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 the most comprehensive AST single panel on the market. The NGP Gram-Negative Panel provides results for twice as many antibiotics per patient sample as legacy AST systems. 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 uniquely 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 Pathologist (CAP) requirements.
"The clearance of our Gram-Negative panel brings us one step closer to combating the surge in antibiotic resistant superbugs. 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," said Steve Lufkin, CEO of Selux Diagnostics.
"There is a critical need for new tools to combat the impact that AMR has on patients. The Selux NGP System brings innovation to the AST space by delivering rapid results and the latest FDA breakpoints as well as room to add new antibiotic therapies as they become available. With the clearance of this Gram-Negative Panel, Selux is able to help optimize therapies for patients with bacterial infections," said James S. Lewis II, PharmD, FIDSA, co-director of antibiotic stewardship at Oregon Health and Science University, and chair, CLSI Antimicrobial Susceptibility Testing Subcommittee.
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 redefining the speed and performance of AST.
For more information on the Selux NGP System, visit www.seluxdx.com.
This platform has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under contract number HHSO100201800013C.
About Selux Diagnostics
Selux Diagnostics is focused on advancing science and technology to improve treatments and outcomes for infectious disease patients. By providing rapid Antibiotic Susceptibility Test (AST) results, Selux is combatting the surge in antibiotic resistant superbugs head-on.
Their groundbreaking Next Generation Phenotyping (NGP) System can decrease the overreliance of broad-spectrum antibiotics, prepare for future bacteria evolution, and can accommodate new antibiotic therapies as they become available. This advance in diagnostics can save lives, allow physicians to prescribe personalized treatments 3-5 days sooner, and shorten hospital stays - providing better, faster care when you need it most. Learn more at seluxdx.com.
Source: Selux Diagnostics