Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company, announces the market release of SeptiCyte® RAPID on Idylla™ as a CE-marked IVD test. SeptiCyte® RAPID is a host-response test1 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 commercialization2 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(3). 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(4). 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(5) held between 15-18 September 2020, Immunexpress presented clinical validation data(6) 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(6).
Herman Verrelst, Chief Executive Officer of Biocartis, reacted: “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(7) 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."
(1) By testing whole blood directly, the assay is able to detect the response of the patient’s immune system to an infection earlier, faster and more accurately than finding the pathogen
(2) As announced on 26 March 2020
(3) Source: https://www.sepsis.org/, last consulted on 24 September 2020
(4) Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, et al. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet (London, England). 2020;395(10219):200-11
(5) International Symposium on Intensive Care and Emergency Medicine
(6) Source: Immunexpress website and on https://www.prnewswire.com/news-releases/immunexpress-presents-data-on-clinical-validation-of-septicyte-rapid-for-diagnosing-sepsis-at-e-isicem-301130702.html, last consulted on 24 September 2020
(7) Used in conjunction with clinical assessments, vital signs and laboratory findings
(8) Available to select countries within the EU and European region. Check availability with your local Biocartis representative