Immunexpress, a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, today announced that SeptiCyte® RAPID has received regulatory clearance by the Australian Therapeutic Goods Administration (TGA). The clearance of the company's flagship medical device by the regulatory body allows for the sale, use and further commercial testing of SeptiCyte RAPID throughout Australia to differentiate infection-positive (sepsis) from infection-negative systemic inflammation response syndrome.

"After trialing SeptiCyte RAPID for the past few years, I am looking forward to seeing the impact of this technology in clinical practice," said Associate Professor Adam Irwin, Principal Research Fellow and NHMRC Emerging Leadership Fellow in paediatric infectious disease at The University of Queensland and Queensland Children's Hospital.

"It is especially gratifying to introduce our product to the Australian healthcare community because it was conceived in Australia by Immunexpress' Chief Scientific Officer Dr. Richard Brandon. The ability to bring our sepsis diagnostic capabilities into the Australian healthcare system marks the latest victory in our growing momentum towards impacting patient lives worldwide," said Rollie Carlson, Ph.D., Chief Executive Officer of Immunexpress. "Patients suspected of having sepsis need swift, precise diagnostics. There's an urgent need to serve this vulnerable patient group, which has pushed us to continue to revolutionize diagnostic capabilities for their critical care."

SeptiCyte RAPID will be sold across Australia via Abacus Diagnostics, with whom Immunexpress has an executed Distributor Agreement. Abacus Diagnostics also serves as the distributor for the Biocartis Idylla™ Platform in Australia.