MRSA Analysis Module – Clinical Study Commenced
2nd April 2019
We are pleased to announce that we have commenced a clinical study to validate clinical performance of APAS Independence’s automatic analysis of Methicillin-resistant Staphylococcus aureus (MRSA). This extends the application of the APAS Independence into surveillance of critical organisms for infection control, which offers additional utility of the instrument.
Samples for the detection of MRSA are routinely and regularly conducted in many hospitals and other health care facilities. Testing for MRSA, along with Urine analysis, accounts for 50% to 70% of the culture plate volume in the target markets of Europe, the US and Australia. Therefore, the completion of MRSA modules will be a significant milestone for LBT. The addition of the MRSA modules, which is implemented for customers as a software update on the APAS system, will further enhance the clinical utility of the APAS Independence and provide increased sales opportunities.
The clinical study, being conducted in partnership with St Vincent’s Hospital, Melbourne, represents the final stage in the development of the MRSA analysis modules. In an approach similar to the 10,000-patient clinical trial used for LBT’s US FDA 510(k) de novo submission that was cleared by the FDA in 2016, APAS results are compared against Microbiologists’ interpretation. LBT have established blinded trial protocols to ensure the data integrity required to support intended regulatory filings and self-certification. This study provides evidence of clinical performance formally validating the modules before regulatory clearance can be achieved and the modules can be released to market. LBT is on track to have MRSA analysis modules available in the EU and Australia in the second half of 2019 under a self-certification process. The MRSA modules will be available in the US after FDA clearance is obtained.
LBT continues to improve its development of analysis modules through in sourcing capability, process improvement and new partnerships with key opinion leaders. This has been a strategic focus over the past 15 months, to transition to a more efficient and scalable research and development process for analysis modules. In the case of MRSA, European reference site, Labor Dr Wisplinghoff in Cologne, Germany, supported the development of the module by capturing thousands of MRSA culture images using the APAS Independence instrument. These images have been used to support the machine learning, software and algorithms development to create early versions of the final analysis modules. In addition, Labor Dr Wisplinghoff conducted performance testing of the modules and results have been accepted for presentation at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) meeting which commences April 13th, 2019.