Automated Imaging Speeds Up Infectious Disease Diagnosis
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By LabMedica International staff writers Posted on 27 Oct 2016 |
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Image: The Automated Plate Assessment System, or APAS, is a platform technology for the automation of culture-plate screening and interpretation (Photo courtesy of Clever Culture Systems).
Automated Plate Assessment System (APAS) is a breakthrough artificial intelligence technology for the automated imaging, image analysis, interpretation and reporting of growth on microbiology culture plates after incubation.
Thousands of agar plates are assessed in busy laboratories every day and currently each one has to be examined by a microbiologist for the presence of significant bacterial colonies. APAS automatically screens, interprets and sorts these plates, freeing up the plate reading bottleneck in laboratory workflows and microbiologists’ time and enabling faster time to patient results.
The US Food and Drug Administration (FDA, Silver Springs, MD, USA) have given 510(k) de novo submission clearance for the APAS as a class II device. 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 USA 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.
The APAS was developed by LBT Innovations (Adelaide, Australia), and has been licensed on a global, exclusive basis to Clever Culture Systems AG (CCS, Bäch, Switzerland), which is integrating APAS with laboratory robotic instrumentation. CCS plans to bring APAS to market in 2017 as an automated stand-alone plate reader (APAS Independence) closely followed by the integrated incubator (APAS Incubot).
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.”
Related Links:
US Food and Drug Administration
LBT Innovations
CCS
Thousands of agar plates are assessed in busy laboratories every day and currently each one has to be examined by a microbiologist for the presence of significant bacterial colonies. APAS automatically screens, interprets and sorts these plates, freeing up the plate reading bottleneck in laboratory workflows and microbiologists’ time and enabling faster time to patient results.
The US Food and Drug Administration (FDA, Silver Springs, MD, USA) have given 510(k) de novo submission clearance for the APAS as a class II device. 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 USA 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.
The APAS was developed by LBT Innovations (Adelaide, Australia), and has been licensed on a global, exclusive basis to Clever Culture Systems AG (CCS, Bäch, Switzerland), which is integrating APAS with laboratory robotic instrumentation. CCS plans to bring APAS to market in 2017 as an automated stand-alone plate reader (APAS Independence) closely followed by the integrated incubator (APAS Incubot).
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.”
Related Links:
US Food and Drug Administration
LBT Innovations
CCS
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