Immunexpress Receives Early Stage Commercialisation Support to Further Develop SeptiCyte® PLUS

Immunexpress receives Early Stage Commercialisation support to further develop SeptiCyte®PLUS — designed to diagnose sepsis accurately within a clinically relevant timeframe.

BRISBANE, Australia (February 18, 2014) – Today, Immunexpress Group (Immunexpress) announced it has received Early Stage Commercialisation support through Commercialisation Australia, an initiative of the Australian Government. The AUD $982,707 grant will support the company’s AUD 2.2 million project, intended to bring the Immunexpress innovative whole blood qRT-PCR diagnostic assay (SeptiCyte® PLUS) to market. SeptiCyte® PLUS is designed to diagnose sepsis accurately within a clinically relevant timeframe.

“This is an important step forward in the development of SeptiCyte® PLUS and our efforts to bring novel sepsis assays to health care centers and patients around the world,” said Dr Roslyn Brandon, President and Chief Executive Officer, Immunexpress. “Based on the results to date, SeptiCyte® PLUS has the potential to make an important impact on the health care community and improve patient outcomes by allowing for earlier diagnosis and targeted antimicrobial treatment within a clinically relevant time frame of under three hours.“

The grant funding, along with existing cash resources, will be used to develop the SeptiCyte® PLUS prototype through to a Laboratory Developed Test (LDT), and make it available for trials through hospital labs at two large health systems in the U.S. along with one major academic hospital in Germany. The prospective data collected through these centers is expected to inform the regulatory pathway and future medical device application for SeptiCyte® PLUS in the U.S.

New technologies that allow for the earlier detection and personalized management of people with, or at risk of, sepsis could significantly reduce the financial burden on health care systems worldwide through reduced patient mortality and morbidity; reduced stays in hospital and intensive care units (ICUs); more targeted use of antibiotics and anti-inflammatories; and reduced antimicrobial resistance.

About Commercialisation Australia
Commercialisation Australia (CA) is an initiative of the Australian Government. It is a competitive, merit-based assistance program offering funding and resources to accelerate the business-building process for Australian companies, entrepreneurs, researchers, and inventors looking to commercialise innovative intellectual property. Early Stage Commercialisation support provides funding for the steps necessary to bring a new product, process, or service to market. The support is aimed at helping companies that have an innovative product with potential, but that need assistance in areas such as, but not limited to, development, market validation, compliance with industry standards, and early sales.

About Sepsis
Sepsis is a life-threatening generalized inflammation caused by the immune system’s response to an infection. Sepsis occurs when chemicals released into the bloodstream to fight the infection and modulate the patient’s immune response trigger a generalized inflammation throughout the body. It is thought that the inflammation creates microscopic blood clots that can prevent nutrients and oxygen from reaching organs, causing them to fail. Severe sepsis can rapidly deteriorate to septic shock, often leading to organ failure and death. Most people recover from mild sepsis, but the mortality rate for severe sepsis or septic shock is nearly 50 percent.

Sepsis is the leading cause of death in ICUs worldwide and is increasing in incidence. Worldwide, there are 18 million cases of diagnosed sepsis per year – and the incidence is rising at 8 to 10 percent annually; in the developed world, an estimated 1,400 people die from sepsis each day (~ 511,000 each year). Patients at risk of sepsis include infants, mothers after childbirth, the elderly, those with weakened immune systems, or those who have experienced significant trauma/injury, invasive surgery, or burns. However, healthy people can also develop and become ill from sepsis.

About SeptiCyte® Technology
The Immunexpress first-in-class SeptiCyte® technology quantifies specific and multiple molecular markers from the patient’s own immune system (‘host response’) for earlier diagnosis, detection, triage, screening, severity assessment, and ultimately for better timing and targeting of drug and other therapies. Results from Immunexpress clinical trials show that biomarkers of the patient’s immune response are more accurate and instructive than pathogen detection for the early detection and management of sepsis. By translating complex molecular signals in an objective score, SeptiCyte® technology provides reports on disease probabilities – aiding clinicians in the management of people with sepsis for improved clinical and economic outcomes. The SeptiCyte® technology is the basis for a range of investigational products in the Immunexpress pipeline, including SeptiCyte® PLUS.

About Immunexpress Group
Immunexpress is a molecular diagnostic company committed to improving outcomes for patients with, and, at risk of, sepsis. The core competency of Immunexpress is the clinical validation of genomic and proteomic biomarkers and the translation of these novel biomarkers into clinical diagnostic and monitoring products that are for readily available platforms, including point-of-care (POC). Immunexpress is a privately-held group of companies with locations in Brisbane, Australia and Seattle, USA. For more information about Immunexpress, visit: immunexpress.com.

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