ADELAIDE-based medical technology company LBT Innovations has begun clinical trials of its Automated Plate Assessment System.
The APAS is an automated culture-plate analysis and reporting system for use in clinical laboratories. It automatically images, analyses and interprets culture plates after incubation.
Healthscope Pathology’s Melbourne and Adelaide laboratories will put the system through its paces by using it to test urine samples and assessing its accuracy and efficiency in screening culture plates for pathogens.
After these two trials in Australia, LBT Innovations will trial APAS at a laboratory in the United States, before making a 510(k) de novo submission to the US FDA in an effort to enable the system to be distributed commercially in the US market. According to LBT, the clinical trials will be structured to meet specific FDA requirements.
Earlier in 2014, studies presented to the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) and the annual meeting of the Australian Society for Microbiology found the APAS prototype matched the findings of teams of experienced microbiologists, without missing a single potential pathogen.
Swiss instrumentation company Hettich is currently incorporating APAS into a bench top culture plate reader and with its auto-incubator. Hettich is in a 50:50 joint venture with LBT to commercialise the APAS technology.