Biocartis announces market release of SeptiCyte RAPID test on Idylla

Biocartis Group has released of SeptiCyte RAPID on Idylla as a CE-marked IVD test. SeptiCyte RAPID is a host-response test that distinguishes sepsis from non-infectious systemic inflammation in patients suspected of sepsis and provides actionable results in about one hour.

The test was developed by Biocartis’ partner Immunexpress Pty Ltd, a US-based molecular diagnostics company, and is now being released as part of Biocartis’ exclusive commercialization of SeptiCyte RAPID on Idylla in Europe.

Sepsis is the body’s life-threatening response to infection, which can lead to tissue damage, organ failure, and death. A recent scientific publication by The Lancet estimated that in 2017 there were 48.9 million cases and 11 million sepsis-related deaths worldwide, which accounted for almost 20% of all global deaths. Early and rapid diagnosis of sepsis is furthermore essential to avoid unnecessary hospital costs or overuse of antibiotics, which leads to greater antibiotic resistance among vulnerable patient populations.

Current diagnostic tests to aid in the diagnosis of sepsis are often unreliable and slow. At the virtual e-ISICEM symposium held between 15-18 September 2020, Immunexpress presented clinical validation data, which demonstrated comparable and reproducible results between Immunexpress’ existing US FDA-cleared test, SeptiCyte LAB, and SeptiCyte RAPID on Idylla. These data are the first validation of a rapid, fully integrated, reproducible, immune response-based sepsis diagnostic test.

Biocartis CEO Herman Verrelst said: “Together with our partner Immunexpress, the SeptiCyte and Idylla technologies joined forces in a single one-step, sample-to-result test that, thanks to the Idylla platform, can now be rolled out globally. As the exclusive distributor of SeptiCyte RAPID in Europe, we are very pleased to offer this test to our existing and new customer base within our well-established European laboratory and hospital network."