NEW YORK – Boston-based biotech startup Selux Diagnostics announced on Thursday that its Next Generation Phenotyping (NGP) System has received 510(k) clearance from the US Food and Drug Administration. The system was cleared along with a panel to determine the antimicrobial susceptibility of Gram-positive bacteria.
The NGP is a rapid antibiotic susceptibility testing platform that can provide results from liquid culture samples in as little as five hours with a throughput of 80 to 100 samples per shift, as previously reported. The system — which relies on labeling and imaging of bacteria in the presence of antibiotics — was awarded breakthrough device designation by the FDA in 2021.
Cleared along with the system was the Selux Gram-Positive Panel, which determines susceptibility to 14 antimicrobials. The NGP Gram-Negative panel is currently under review by the FDA, the firm noted in a statement.
"This clearance represents a significant advance in infectious disease care and the fight to address antibiotic resistance," said Selux CEO Steve Lufkin. "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," he added.
Selux has previously been awarded funding from the Biomedical Advanced Research and Development Authority (BARDA) and last year closed a $50 million Series C financing round and $30 million loan to support its commercialization efforts.