First Placement of APAS Independence into US Lab
26 November 2018
LBT Innovations is pleased to announce that our joint venture company, Clever Culture Systems (CCS) has placed the first APAS® Independence instrument into a United States medical centre, which will act as a key opinion leader ahead of expected United States (US) commercial market launch in 2019.
Hennepin Healthcare System (HHS) includes the Hennepin Healthcare Research Institute (HHRI) and the Hennepin County Medical Centre (HCMC), focused on delivering comprehensive medical service to the Minneapolis community. HCMC is a nationally recognised Level I Adult Trauma Centre and Level I Paediatric Trauma Centre and acute care hospital. HHS also maintains an integrated clinic system with primary care clinics located in Minneapolis and across Hennepin County. The HCMC Microbiology Laboratory provides a full range of services including all diagnosis of bacterial, viral, mycotic, and parasitic infections, including extensive testing and reporting or antimicrobial susceptibility results.
A Memorandum of Understanding has been executed between CCS and HHRI to formalise the collaboration. Training and commissioning of APAS® Independence will occur over the coming weeks and integration into the HHRI workflow is expected in early 2019. The intention is that once fully operational, the centre will become a North American centre of excellence for APAS® Independence. Dr Glen Hansen, Director of Microbiology at HHRI has a reputation for innovation that improves patient outcomes and will lead the establishment of the centre of excellence for the APAS® Independence.
Dr Hansen stated: “This collaboration is another example of Hennepin Healthcare Centre and Hennepin Healthcare Research Institute, employing the latest technology to deliver quality and timely results to our customers. We expect this collaboration will further benefit our customers and their patients by bringing together our clinical expertise and with the artificial intelligence of the APAS® Independence, further enable the microbiology laboratory in its delivery of accurate and timely diagnosis.”
The United States is the world’s single largest pathology market and entry into that market is a key strategic goal for LBT and CCS. The APAS® technology remains the only FDA cleared instrument, indicated for use as a Class II medical device, following the US Food and Drug Administration (FDA) clearance for the manual version, the APAS® Compact in October 2016. To support commercialisation and sales in the US, a 510(k) is required to submit to the US FDA for the automated instrument, the APAS® Independence. The Company will provide a progress update on the submission before the end of 2018.
LBT CEO and Managing Director, Brent Barnes, said:
“We are excited to work with Dr Hansen and his team and believe we have found a world leading group that will objectively support our push into the US market. The partnership will enable us to leverage this experience into other laboratories in the US. The HHRI team will work with us to carry out a rigorous assessment of the APAS® Independence, enabling us to tailor workflow solutions to the local US requirements and kick start the early sales process. The input of innovative key opinion leaders like Dr Hansen is crucial to maintaining our current technology leadership position.”