Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces the market release 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 (‘Immunexpress’), a Seattle-based (US) 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.
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. I believe we can make a real difference with this test that now allows to detect the likelihood of sepsis early on and provides actionable results to clinicians in approximately one hour for critically-ill patients suspected of sepsis, where every second counts–Herman Verrelst, Chief Executive Officer of Biocartis