Automated Imaging Speeds Up Infectious Disease Diagnosis

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