Selux said that the in-vitro antimicrobial resistance test will help clinical labs deliver targeted therapeutic results days faster than current standard of care, and supports the development of personalised antibiotic therapies
FDA approves Selux’ rapid antibiotic susceptibility test. (Credit: CDC on Unsplash)
US-based biotech start-up Selux Diagnostics has received the US Food and Drug Administration (FDA) 510(k) approval for its Next Generation Phenotyping (NGP) System.
Selux said that its new NGP system is a rapid antibiotic susceptibility (AST) testing platform that delivers targeted therapeutic results days faster than the current standard of care.
The in-vitro antimicrobial resistance test is designed to determine a bacteria’s susceptibility to 14 specific antimicrobial agents on the Selux Gram-Positive Panel.
The NGP Gram-Negative panel is currently being reviewed by the FDA, said the company.
Selux Diagnostics CEO Steve Lufkin said: “This clearance represents a significant advance in infectious disease care and the fight to address antibiotic resistance.
“Our ground-breaking 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. We thank all our employees, partners, and advisors who contributed to this tremendous accomplishment.”
Selux said that it is fighting the global health crisis of deaths from superbugs by redefining the speed and performance of AST, which enables the personalised antibiotic therapy.
The NGP platform is supported with federal funds from the US Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR), and Biomedical Advanced Research and Development Authority (BARDA).
In September 2021, Selux has received the FDA breakthrough device designation for the NGP platform, to deliver phenotypic rapid AST results from both positive blood samples and isolated colonies.
Last year, Selux has closed a $30m senior secured term loan from Oxford Finance, a specialty finance firm that provides senior debt to life sciences and healthcare companies.
CLSI Antimicrobial Susceptibility Testing Subcommittee chair 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 personalized therapies for infected patients.”