FDA clears APAS imaging and software technology as a Class II medical device
APAS enables the faster diagnosis and reporting of infectious diseases
Clever Culture Systems (CCS), the Swiss-based joint venture between Australian medical technology company LBT Innovations and Swiss company Hettich, has received clearance of its 510(k) de novosubmission to the US Food and Drug Administration (FDA) for APAS (Automated Plate Assessment System) as a Class II medical device.
APAS is a breakthrough artificial intelligence technology for the automated imaging, image analysis, interpretation and reporting of growth on microbiology culture plates after incubation, and 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.
'FDA clearance follows rigorous interrogation and validation of the capabilities of APAS. The successful clinical trial programme 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,' said Brent Barnes, CEO of LBT Innovations.
Lusia Guthrie, who recently retired as 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.
LBT Innovations has two class-leading products in microbiology automation: MicroStreak, which provides automated culture plate streaking, and APAS. The company also has a third product in early development, WoundVue, a proposed automated solution to assist in the management of chronic wounds.