Develoment and clinical evaluation of a POC theranostic assay to inform therapy choice in Acute Respiratory Distress Syndrome

"Acute Respiratory Distress Syndrome (ARDS) is a life threatening condition in critically ill patients, caused by infection or injury. Infection and injury induce inflammation in the lungs, causing the lungs to fill up with fluid thus preventing the normal movement of oxygen from the lungs to the blood, for distribution to the rest of the body. ARDS often progresses to further injury to other organs in the body, and is associated with high rates of mortality or long term disability in survivors.

The incidence of ARDS is estimated to be 40,000 patients annually in the UK, 200,000 in the US and 3 million globally. Mortality rates range between 30-45%, depending on initial severity at diagnosis. There is no effective drug treatment for the condition despite numerous clinical trials to evaluate possible candidates. However, new evidence suggests that previously tried and discounted drugs may benefit certain patient sub-groups. Medical experts within our project consortium have found that ARDS patients with very high levels of certain markers of inflammation are more likely to respond to several therapies. Several biomarkers (substances we can measure in blood) have been identified to allow identification of these hyper-inflamed patients. This is the essence of stratified medicine, where a diagnostic test can inform individual therapy decisions, also known as theranostics. To allow rapid identification of the hyper-inflamed patient with ARDS, and hence guide the most effective therapy at the point of admission to Intensive Care Units, a near-patient theranostic test is required.

Working with our clinical and academic partners, Randox have developed a test to identify hyper-inflamed ARDS patients and confirmed this works by testing over 120 blood samples. This project proposal will further develop this biomarker test to allow rapid near-patient analysis, using our new point of care (POC) diagnostic analyser. Once ready, our clinical / academic partners at Queen's University Belfast will co-ordinate a multi-centre clinical evaluation across Intensive Care Units in the UK to show that the test can be used at point of care to accurately stratify patients into hyper-inflamed and hypo-inflamed phenotypes (sub-groups). This will inform therapy decisions.

The project thus aims to develop a theranostic ARDS test and prove that it is effective in identifying those critically ill patients that are more likely to respond to a tailored therapy."