Australian medical technology company LBT Innovations (ASX: LBT) has received pre-market 510(k) clearance from the US Food and Drug Administration for its APAS (Automated Plate Assessment System) Independence autonomous medical device with associated urine analysis module.
The clearance was achieved through the Clever Culture Systems (CCS) joint venture – held 50:50 by LBT and German automated laboratory equipment manufacturer Hettich Holding Beteiligungs-und Verwaltungs-GmbH – and represents the second of its kind following clearance of the manual APAS Compact model in October 2016.
It is the final regulatory milestone for APAS Independence and will enable CCS to ramp up commercial sales to more than 5,000 clinical laboratories across the US – representing the single largest pathology market in the world.
The company has already reached out to over 800 laboratories, and said it had received positive initial interest from potential customers.
Managing director Brent Barnes classed the clearance milestone for APAS Independence as a “hugely exciting development” for LBT.
“It secures our first mover advantage as the only FDA-cleared Class II commercial product of its kind available for sale in the US,” he said.
“The focus now is on ramping up commercialisation activities in the region to convert [market] interest into early sales.”
Thousands of agar plates are assessed in laboratories across the world every day and currently, each of those needs to be examined by a microbiologist for the presence of clinically-significant bacterial colonies.
APAS Independence takes the manual work out of culture identification by combining expertise across three disciplines – artificial intelligence, software and imaging – to create a new platform technology for intelligent image interpretation.
The device has been designed to automatically screen, interpret and sort culture plates, overcoming the bottleneck in laboratory workflows and enabling faster delivery of patient results.
Unlike the manual-loading APAS Compact, the Independence is fully-automated with the ability to process over 200 culture plates per hour, which is reported to be at least three times faster than manual culture plate reading.
The Class II medical device is able to differentiate culture plates showing bacterial growth from those that don’t, without the need for highly-skilled microbiological assistance or further intervention.
It is currently the only commercially-available instrument for the automatic reading of culture plates in the US.
In April, LBT kicked-off a study to validate the clinical performance of APAS Independence’s ability to automatically analyse critical organisms for infection control via artificial intelligence technology, specifically Methicillin-resistant Staphylococcus aureus (or MRSA) which is routinely tested for in hospitals and health care facilities.
Testing for MRSA, along with urine analysis, accounts for up to 70% of culture plate volumes in LBT’s target markets of Europe, the US and Australia.
The clinical study, conducted in partnership with Melbourne’s St Vincent’s Hospital, represents the final stage in the development of the MRSA analysis modules for the device.
LBT said the addition of the MRSA modules – which would be implemented for customers as a software update on the APAS system – could further enhance the clinical utility of the APAS Independence and provide increased sales opportunities.