CarbGem and its parent company, NexGen have filed for manufacturing and marketing approval for AI software that estimates the bacterial species of bacterial infections and supports diagnosis and selection of therapeutic agents. The AI software analyzes Gram-stained images of urine tests to estimate the species of bacteria. the AI software is linked to information on antibiograms, which examine the susceptibility of microorganisms isolated at medical institutions to various antimicrobial agents, to assist in the selection of antimicrobial agents for the estimated species of bacteria. The system is expected to be used in clinics, hospitals, and emergency rooms where specialists are not available at night.
When an infection is suspected, specimens such as urine must be Gram-stained, and then observed under a microscope to estimate the bacterial species and prescribe an appropriate antimicrobial agent. In the past, Gram staining was time-consuming and labor-intensive, and microscopic observations were read inconsistently. CarbGem has developed a compact staining device that automatically performs Gram staining and BiTTE (Bacterial infection teller and treatment estimator (BiTTE)), an AI software that estimates bacterial species and supports the selection of antimicrobial agents. CarbGem and NexGen have applied for manufacturing and marketing approval of the BiTTE AI software as a programmed medical device, ahead of the automatic Gram staining device, and expect to receive approval in fiscal 2024.