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() has completed two comprehensive clinical trials of its pioneering culture-plate analysis technology the Automated Plate Assessment System (APAS®) at the laboratories of Healthscope Pathology in Melbourne and Adelaide.
The trials successfully tested the efficacy of the APAS technology in detecting and reporting the presence of disease-causing pathogens in urine samples from a total of 4300 patients.
A full report of the findings is being submitted to the United States Food and Drug Administration (FDA) prior to the commencement of a US trial early in 2015.
LBT is maintaining close consultation with the FDA to confirm that its trial protocols continue to meet the strict guidelines required for a 510(k) de novo submission which will be required before APAS can be distributed commercially in the US market.
LBT has two products in microbiology automation in PREVI® Isola which provides automation of culture plate streaking and APAS® a breakthrough in automated culture plate imaging interpretation and reporting.
APAS specifically addresses the automated imaging analysis and interpretation of culture plates following incubation.
LBT has entered into a Joint Venture with Hettich AG Switzerland to drive the commercial development and global distribution of APAS instrumentation and software products.
LBT has an exclusive global licence agreement with French diagnostics company bioMérieux to manufacture and market PREVI® Isola and receives ongoing royalty payments.
LBT also has a third product in development Woundvue™ a proposed automation solution to assist in the management of chronic wounds.
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