Global Progress for APAS Independence as MRSA Trials Commence

15 May 2019

Press Release

Clever Culture Systems continues its charge into the American and European markets with the APAS Independence, expected to receive FDA clearance later this quarter.

APAS Independence Pre-Sales

A revolutionary platform technology that automates culture-plate screening and interpretation, the APAS Independence and analysis module for urine have commenced pre-sales in the US, with FDA approval likely in the near future.

Clever Culture Systems’ General Manager Peter Bradley said commercial release of the instrument in Europe is also expected once a clinical study of a new analysis module for the detection of Methicillin-resistant Staphylococcus aureus (MRSA) is completed.

MRSA Trial Underway

The MRSA trial, underway at St Vincent’s Hospital in Melbourne, follows work with European company Labor Dr Wisplinghoff, who supported the development of the MRSA module through the capture of more than 14,000 culture plate images using the APAS Independence.

Mr Bradley said MRSA is one of the most common specimen type used on culture plates in the EU, accounting for up to 35 per cent of their total culture plate volume.

“This work is critical to our self-certification regulatory processes in the EU and Australia, through CE Mark and the TGA, respectively. The completion of the MRSA analysis module in the coming months will open up access to the European market,” he said.

“The clinical data we released last month for the MRSA module is extremely promising, and shows the system performed with a sensitivity of 100% and a specificity of 98.1%.”

“We look forward to completing this trial, and to the official commercial release of the modules in Europe and Australia, as well as the official release of the instrument following FDA clearance in the United States imminently,” Mr Bradley concluded.