Diagnostic company secures regulatory green light for detection of life-threatening condition

MedTech & Diagnostics News: A Brisbane-based molecular diagnostic company has announced the regulatory clearance of its test for sepsis by the Therapeutic Goods Administration (TGA).

The Cost of Sepsis in Australia report shed light on the staggering statistics surrounding sepsis cases, estimating over 90,000 instances annually with direct and indirect costs reaching $700 million and $4 billion respectively.

Early identification of sepsis is difficult for many reasons. In the early stages of the disease, patients present with inflammatory clinical signs which may be early indicators of a septic response, but which are also common to many other non-infectious conditions. Proof of infection by the conventional ‘gold standard’ criterion of culture positivity lacks timeliness and cultures are negative in a significant fraction of retrospectively diagnosed sepsis cases.

With this regulatory green light, SeptiCyte RAPID addresses a clinical need for more rapid and accurate differentiation of sepsis from infection-negative systemic inflammation response syndrome (SIRS) within a clinically actionable (~1 hour) timeframe.

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, expressed anticipation for the practical implications of SeptiCyte RAPID. Having trialled the technology over the past few years, with funding through the Medical Research Future Fund (MRFF) Genomic Health Futures Mission, he highlighted its potential to significantly influence clinical practice.

“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 Dr Rollie Carlson, CEO of Immunexpress.

Recognising the urgency of serving patients suspected of sepsis, he stressed the need for swift and precise diagnostics.

“There’s an urgent need to serve this vulnerable patient group, which has pushed us to continue to revolutionise diagnostic capabilities for their critical care,” Dr Carlson said.

Immunexpress has strategically partnered with Abacus Diagnostics to facilitate the sale and distribution of SeptiCyte RAPID across Australia. Abacus Diagnostics, a distributor for the Biocartis Idylla™ Platform in Australia, aligns with Immunexpress in their mission to make innovative diagnostic solutions accessible to healthcare professionals and, ultimately, the patients in need.

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