Multi-centre clinical trial data showed the test, known as SeptiCyte® Lab, was successful in diagnosing sepsis with a high performance1 within three hours of receiving samples.
Athlomics Chief Executive Officer Dr Roslyn Brandon said the decision to develop SeptiCyte® Lab resulted from interactions with critical care clinicians, surgeons and oncologists who stressed the importance of earlier diagnosis of sepsis.
“A relatively quick test such as SeptiCyte® Lab will empower clinicians to more aggressively treat sepsis,” Dr Brandon said.
“Combined with standard clinical assessments, it will allow a more complete picture of the disease and potentially be used to individualise patient care and reduce the need for long term antibiotics use.
Brisbane’s Mater Health Services Director of Pathology, Professor Deon Venter, said he was excited by the potential life- saving capabilities of the SeptiCyte® test.
“Currently one third of patients who contract severe sepsis are likely to die from the disease. It is the highest non- coronary cause of death in Intensive Care Units,” Professor Venter said.
“The gold standard diagnostic for sepsis is currently microbial culture which only provides a result in about half the cases of suspected sepsis; it is slow and prone to false positives and negatives,” Professor Venter said. “With SeptiCyte® Lab we aim to deliver results within three hours of receiving samples, with extremely high accuracy.”
Royal Brisbane & Womens’ Hospital’s Professor Jeff Lipman said SeptiCyte® Lab was a significant advance because of its future potential to monitor severe sepsis patients and detect sepsis in patients at risk.
“Sepsis is caused by the body's response to infection and is the abnormal response of the immune system of the patient—frequently leading to septic shock and death. A quick diagnosis can be crucial.” Professor Lipman said.
Associate Professor Jeffrey Presneill and Dr John Morgan, Senior Specialists, Intensive Care Unit, Mater Health Services, Brisbane, Australia, said: "This simple pathology test shows great promise in the management of patients with potentially life-threatening microbial infection. Such individuals often develop their illness within hours, and deteriorate quickly. “
“The Athlomics SeptiCyte® assay is designed to provide individualized diagnostic information to guide clinicians caring for such critically-ill patients, at a time when early intervention could change outcome."
Performance is measured by the area under a receiver operator curve (AUC), which varies from 85% to 95% depending o the clinical comparisons being performed.
About Sepsis
Sepsis, a usually fatal medical condition caused by the body’s response to infection, affects 5 to 10% of all hospital patients leading to an increase of about $5 billion in US healthcare costs annually. The rate of death from severe sepsis ranges from 30 to 50% despite advances in critical care. In the US, approximately 750,000 cases of severe sepsis occur each year, at least 250,000 of which are fatal. It is well accepted that better clinical outcomes are achieved when treatment is begun immediately after diagnosis. Babies, elderly and those with weakened immune systems are most likely to get sepsis. But even healthy people can become deathly ill from it. The cost of treating septic patients in ICU can add $5,000 or more per day to a patient’s bill, where treatment lasts at least two days and often more than 20 days. Since one in eight ICU patients are at risk for sepsis, the sepsis healthcare costs in the United States exceed $17 billion per year.
About SeptiCyte® Lab
Athlomics’ SeptiCyte® Lab test is a multiplex molecular method for diagnosing sepsis using the patient’s ‘host response’. The test translates the complex signals occurring in the cells of the immune system into an objective score indicating the likelihood of the patient having sepsis. SeptiCyte® testing enables clinicians to diagnose sepsis earlier, and act upon this diagnosis with more certainty. The test could potentially also be used for regular monitoring of patients over time, in order to assess the response to treatment. The clinical value of SeptiCyte® testing was demonstrated in a multi-centre, blinded clinical trial. SeptiCyte® Lab was successful in distinguishing sepsis from other forms of systemic inflammation with a performance of 85 to 95% (p<0.01)2. The test is currently offered through the Mater Pathology Services and requires 5 ml of whole blood in PreAnalytiX PAXgene™ tubes. Options for paediatric and neonatal use are currently being evaluated.
About Athlomics
Athlomics commenced business in 2006 in Brisbane, Australia. Its business development office is now based in Seattle, WA, USA, where it has a wholly-owned US subsidiary, ImmuneXpress Inc. Athlomics’s broader technology is designed for the diagnosis and monitoring of immune system health and wellness. Using a sub-set of its patented blood immune system biomarkers, Athlomics is initially focusing on sepsis, a highly complex disease process for which no single biomarker is ever likely to be useful. Clinical trials are currently underway to determine the value of SeptiCyte® technology in the continuous monitoring of sepsis patients and their immune system’s response to therapy.
More Information Dr Roslyn A. Brandon Managing Director & Chief Executive Officer Athlomics Group of Companies AU Cell: +61 419 127 683 US Cell: +1 206 351 2662 Email: Roz.Brandon@athlomics.com
