Boston-based biotech Selux Diagnostics announced today that the US Food and Drug Administration (FDA) has granted the company a 510(k) clearance for its rapid in vitro antibiotic susceptibility testing platform.
The FDA clearance means the company can now commercialize its Next Generation Phenotyping (NGP) System, which provides susceptibility results within 24 hours for 14 antimicrobial agents on the Selux Gram-positive panel. The FDA is also reviewing Selux's NGP Gram-negative panel.
Selux has received $60.8 million in funding from the Biomedical Advanced Research and Development Authority to support development of the NGP platform, which the company says provides susceptibility results days faster than the current standard of care, shortening the time to selection of targeted antimicrobial therapy for patients with bacterial infections.
This clearance represents a significant advance in infectious disease care and the fight to address antibiotic resistance.
"This clearance represents a significant advance in infectious disease care and the fight to address antibiotic resistance," Selux CEO Steve Lufkin, MBA, said in a company press release. "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."