- LBT Innovations (LBT) is granted FDA clearance for its culture plate reading technology, APAS Independence
- The clearance enables both the urine and MRSA analysis modules to be sold commercially to customers in the United States
- The company says the APAS technology remains the only regulatory-cleared device able to automatically read and interpret growth on microbiology culture plates
- LBT Innovations has risen 10 per cent, trading at 11 cents
Medical technology company LBT Innovations (LBT) has been granted FDA clearance for its culture plate reading technology.
The United States Food and Drug Administration has given 510(k) clearance for LBT’s joint venture company, Clever Culture Systems, APAS Independence with MRSA analysis module.
The Automated Plate Assessment System (APAS) automates culture-plate screening and interpretation, which is said to meet the demands of the fast-growing automated pathology market. The APAS Independence automatically screens, interprets and sorts the plates, enabling faster delivery of patient results.
The clearance enables both the urine and MRSA analysis modules to be sold commercially to customers in the United States.
MRSA, or Methicillin-resistant Staphylococcus aureus, is one of the leading causes of multi-drug resistant infections, which sees MRSA-infected patients become 64 per cent more likely to die than people with drug sensitive infections.
The approval follows a study by Johns Hopkins Hospital which found APAS Independence could identify all positive MRSA specimens, including five positive samples previously missed by the microbiologists.
LBT CEO and Managing Director Brent Barnes said the FDA demonstrates its industry leading use of artificial intelligence for clinical microbiology.
“It is a testament to the ability of our technical and regulatory teams that no one else has been able to achieve what we have delivered with our APAS technology,” Brent Barnes said.
LBT Innovations rose 10 per cent, trading at 11 cents at 12:45 pm AEDT.