Australian medical technology company LBT Innovations (ASX:LBT), a leader in medical technology automation using artificial intelligence, has announced the commencement of its clinical study to validate the clinical performance of APAS Independence’s automatic analysis of Methicillin-resistant Staphylococcus aureus (MRSA).
This company said this study extends the application of the APAS Independence into surveillance of critical organisms for infection control.
LBT said testing for MRSA, along with urine analysis, accounts for 50-70 per cent of the culture plate volume in its target markets of Europe, the US and Australia.
The clinical study, being conducted in partnership with St Vincent’s Hospital in Melbourne, represents a final stage in the development of the MRSA analysis modules.
The company said it is on track to have MRSA analysis modules available in the EU and Australia in the second half of 2019 under a self-certification process. The MRSA modules will be available in the US after FDA clearance is obtained.
According to CEO and managing director Brent Barnes, “The commencement of the MRSA clinical trial is another exciting development that will support the continued commercialisation of the APAS technology by increasing the number of customers where the APAS Independence provides clinical utility. It also signals LBT’s transition from technology invention to a software manufacturing process for future analysis modules.
“I am also pleased to report that we have developed our own custom clinical trial platform to support the delivery of future clinical studies and ensure compliance with all regulatory requirements.
“Finally, I’d like to acknowledge the hard work of our analysis module development team and reference site partners. The milestone has been achieved through an industry leading collaboration between three different disciplines across microbiology, software development and artificial intelligence.”