LBT Innovations receives green light for EU market entry, completes MRSA clinical study
CE Mark self-certification has been completed for LBT Innovations’ APAS Independence instrument.
Medical technology company LBT Innovations (ASX: LBT) is set to take its artificial intelligence-inspired APAS Independence instrument to Europe after obtaining the highly prized CE Mark certification – a stamp of regulatory approval issued to products allowing their sale across the European continent.
The APAS instrument – or Automated Plate Assessment System – is based upon LBT’s intelligent imaging and machine learning software and serves as a platform for automating culture-plate screening and interpretation.
The instrument was first created via a collaboration with computer scientists at the University of Adelaide’s Australian Institute of Machine Learning (AIML) and is aimed at the fast‑growing automated pathology market.
APAS automatically screens, interprets and sorts pathological samples, thereby overcoming the bottleneck in lab workflows which enables faster delivery of patient results.
It remains the only US FDA-cleared artificial intelligence technology for automated imaging, analysis and interpretation of culture plates following incubation.
Parallel clinical study results
In parallel to the CE Marking, LBT also confirmed that its MRSA analysis module had successfully met the target sensitivity and specificity requirements, as part of a clinical study which was first commenced in April.
The clinical study was conducted in partnership with St Vincent’s Hospital in Melbourne and compared the results from APAS Independence against an independent microbiologist’s interpretation.
The MRSA analysis module is particularly important for the launch of the APAS Independence in the EU where testing for MRSA is much higher than in other regions, due to greater requirements for infection control screening.
As things stand, MRSA and urine testing account for 50-70% of the specimens processed in the majority of laboratories. The high negativity rate of MRSA tests, which LBT says “can be over 95%”, makes it particularly well suited to the APAS technology which automatically removes negative plates from the workflow, therefore providing greater value to customers.
According to LBT, the APAS Independence with MRSA analysis module successfully met the sensitivity and specificity requirements, providing the clinical validation of the technology required for CE Mark regulatory clearance.
Going to market
With its analysis module now approved for the EU, the next steps are “finalisation of documentation” and making it available for sale. The medical technology company said this would take please within the next two weeks and expected to be finalised by the end of September 2019.
The EU is considered as one of the largest microbiology markets, representing around 35% of the global market.
Via its 50%-owned joint venture company Clever Culture Systems (CCS), LBT Innovations will initially target the German and UK markets, as they are the two largest microbiology markets in the region.
Germany and the UK collectively have an estimated 1,200 clinical laboratories, of which more than 350 are expected to meet the APAS Independence target customer profile, by processing over 400 plates a day.
As part of a concerted sales offensive, LBT said that over 130 potential laboratory customers have been identified with several laboratories expected to receive placements of an APAS Independence for performance evaluation prior to a potential purchase order.
The company did put a lid on any speculation of imminent clientele by saying that the “anticipated conversion of these early sales opportunities will take time”, as the sales process can require touchpoints with multiple stakeholders as well as a lengthy evaluation of the technology.
Beyond Europe
In addition to Europe, LBT intends to market its MRSA module and APAS Independence solution in Australia and the US.
The MRSA analysis module will be made available for sale in Australia under the company’s existing TGA registration, while in the US, LBT intends to obtain approval from the FDA in the foreseeable future.
“FDA 510(k) submission for the MRSA analysis module is expected in the first quarter of 2020,” the company said.
“CE Marking for the APAS Independence is an important step towards completing the company’s market launch strategy to have a regulatory cleared instrument available for sale in Australia, the EU and the USA,” said Mr Brent Barnes, chief executive officer and managing director of LBT Innovations.
“Furthermore, it provides our customers in the EU with a further technology validation and provides the catalyst to build on our sales activities in the region,” he added.