APAS Independence’s CE mark certification & MRSA analysis module

 September 16th, 2019

Press Release

We are excited to announce that the Conformité Européene or CE Mark self-certification has been completed for the APAS Independence. CE Marking for the instrument enables the APAS Independence to be sold in all member countries within the European Union.

The CE Mark registration has been completed to coincide with the completion of the clinical study for the MRSA analysis module performed by key technology partner LBT Innovations. The APAS Independence with associated MRSA analysis module successfully met the target sensitivity and specificity requirements of the study. It will be made available for sale soon following finalisation of the documentation required to complete the Declaration of Conformity for CE Mark registration.

Importance of MRSA testing in Europe

Testing for MRSA is much higher in the European Union than in other regions due to greater requirements for infection control screening. As such, MRSA testing, combined with urine, accounts for 50-70% of the specimens processed in the majority of laboratories. The high negativity rate of MRSA tests, which 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.

Showcasing the APAS Independence in Europe

The European Union is one of the largest microbiology markets, representing 35% of the global market.

The Clever Culture Systems team will be showcasing the APAS Independence at the IBMS Congress 2019 in Birmingham later this month as well as at ECCMID in Paris in early 2020.

Outside of the European Union, the MRSA analysis module will be available in Australia and in the United States after FDA clearance is obtained in early to mid 2020.

General Manager of Clever Culture Systems, Peter Bradley said:

“CE Marking for the APAS Independence provides our customers in the EU with a further technology validation for the instrument and provides Clever Culture Systems with the catalyst to build on our reach in the region.”