Clever Culture Systems AG (CCS), the Swiss based joint venture between Australian medical technology company LBT Innovations Limited and Hettich AG (Switzerland) has received clearance of its 510(k) de novo submission to the US Food and Drug Administration (FDA) for APAS® as a Class II medical device.
APAS® (Automated Plate Assessment System) is a breakthrough artificial intelligence technology for the automated imaging, image analysis, interpretation and reporting of growth on microbiology culture plates after incubation. APAS® enables the faster diagnosis and reporting of infectious diseases.
Developed by LBT Innovations, APAS® has been licensed on a global, exclusive basis to CCS, which is integrating APAS with laboratory robotic instrumentation. CCS is targeting to bring APAS to market in 2017 as an automated stand-alone plate reader (APAS® Independence) followed by the integrated incubator (APAS® Incubot).
The 510(k) de novo submission used a manual version of APAS to test 10,000 patients in a series of clinical trials conducted in Australia and the US over a 12-month period. In each trial, APAS achieved its target primary endpoints and the results matched or exceeded the findings of a panel of experienced microbiologists.
Mr Brent Barnes, CEO of LBT Innovations, said, “FDA clearance follows rigorous interrogation and validation of the capabilities of APAS. The successful clinical trial program completed in 2015 and clearance by FDA also validate the underlying technology that is the core platform of our Company’s vision to integrate imaging with interpretative intelligence to deliver faster and more secure diagnoses for patients. FDA clearance is a fitting tribute to the many years of painstaking work by LBT’s staff and partners, who together have made our shared vision a reality.”
Mrs Lusia Guthrie (recently retired LBT CEO and Chairman of CCS), confirmed that CCS is in continuing discussions with significant global diagnostics companies for the licensing of the APAS product portfolio, including APAS Independence and APAS Incubot, plus flow-on product opportunities on the drawing board all aimed at the clinical microbiology laboratory.
Source: LBT Innovations Limited