Immunexpress is a host response molecular diagnostic company, committed to improving clinical and economic outcomes for suspected sepsis patients. On 24 January 2018, Biocartis and Immunexpress announced their partnership agreement aimed at the development of SeptiCyte® RAPID on Idylla™. The partnership was expanded on 26 March 2020 with the co-commercialization of SeptiCyte® RAPID where Biocartis acts as the exclusive lead distributor in Europe and Immunexpress leads the commercialization activities in US. On 6 October 2020, SeptiCyte® RAPID was released in Europe as a CE-marked IVD test and on 30 November 2021 it received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
Sepsis
Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection.1 Sepsis is a manifestation of the body’s extreme over-response to an infection. It is a life-threatening medical emergency. Infections that lead to sepsis most often start in the lung, urinary tract, skin, or gastrointestinal tract. Without timely treatment, sepsis can rapidly lead to tissue damage, organ failure, and death.2 3
Today, diagnosing sepsis is challenging because conventional techniques such as blood culture or the detection of sepsis-related biomarkers such as lactate and procalcitonin are slow and often not fully accurate.4
At the time of treatment, physicians disagree on the right treatment in 40-60% of cases5
because currently there are no accurate diagnostics available to deliver a result, which leads to the widespread overuse of antibiotics.6
Costs of sepsis treatment can be quite substantial. Treatment often involves a prolonged stay in the intensive care unit and complex therapies. People with sepsis are two to three times more likely to be readmitted to the hospital than people with many other conditions, such as heart failure or chronic obstructive pulmonary disease. Sepsis is one of the most expensive health conditions with annual healthcare costs estimated at over USD 57 billion in the US alone.7
Development of sepsis may also be linked with other illnesses like pneumonia.8
- 1Singer M, Deutschman CS, Seymour CW, et al. The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA. 2016;315(8):801–810.
- 2https://www.global-sepsis-alliance.org/https://www.global-sepsis-allian…
- 3https://www.cdc.gov/sepsis/what-is-sepsis.html
- 4https://www.global-sepsis-alliance.org/https://www.global-sepsis-allian…
- 5https://immunexpress.com/about-sepsis/, last consulted on 29 October 2021
- 6https://immunexpress.com/about-sepsis/, last consulted on 29 October 2021
- 7https://journals.lww.com/ccmjournal/Fulltext/2021/12000/Sepsis_Among_Me…
- 8https://www.nigms.nih.gov/education/fact-sheets/Pages/sepsis.aspx
SeptiCyte® RAPID
SeptiCyte® RAPID revolutionizes sepsis diagnosis and treatment, with actionable results available in about one hour. Thanks to SeptiCyte® technology, a patient’s immune response can be assessed by quantifying and analyzing gene expression signatures from whole blood.1 By testing whole blood directly, the assay can detect the response of the patient’s immune system to an infection earlier, faster and more accurately than methods that rely on identifying pathogens. As such, SeptiCyte® host response results allow clinicians to better interpret positive and negative pathogen results, empowering them to swiftly differentiate systemic inflammatory response syndrome (SIRS) from sepsis in critically ill patients to be admitted to the ICU.
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’ first 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.
SeptiCyte® RAPID was released in Europe as a CE-marked IVD test and on 30 November 2021 it received 510(k) clearance from the U.S. Food and Drug Administration (FDA).