First of its kind diagnostic for measuring surfactant in multifactorial Acute Respiratory Distress Syndrome (ARDS) patients developed using SIME’s Clinical AI platform
SIME Diagnostics, a commercial stage company pioneering rapid intensive care diagnostics, today announced the publication of a peer-reviewed study demonstrating that the company’s point-of-care AI platform can identify ARDS patients with low surfactant concentration.
The preliminary study, entitled “Reduced Levels of Pulmonary Surfactant in COVID-19 ARDS“, was published by Nature in Scientific Reports [ https://doi.org/10.1038/s41598-022-07944-4 ].1
The study compared levels of surfactant in intensive care COVID-19 patients with healthy controls, using a novel diagnostic device based on spectroscopy and AI.2 The clinical investigators concluded that COVID-19 patients have markedly reduced surfactant levels, and in the most severe cases patients experience a 60% reduction. Without sufficient surfactant, the lungs are unable to effectively exchange oxygen and carbon dioxide – resulting in ARDS, a life-threatening condition that develops in up to 75% of COVID-19 patients admitted to the ICU.3
At the start of the COVID-19 pandemic, SIME published a letter in Critical Care examining the clinical similarities between ARDS and Neonatal Respiratory Distress Syndrome (NRDS).4 The letter outlined how SIME’s Clinical AI Platform, proven to rapidly predict NRDS in pre-term babies, could also enable early targeted care in ARDS and COVID-19 ARDS patients.
SIME then developed the world’s first diagnostic for measuring surfactant in bronchoalveolar fluid, as described in the new paper. This innovative approach was developed in six weeks using SIME’s Clinical AI Platform and proprietary datasets generated during previous clinical trials. The diagnostic has since been optimised to analyse routinely extracted tracheal fluid, ensuring suitability for point-of-care. This refined diagnostic is currently being validated in a pioneering clinical study.5
“We moved quickly when we realised that our platform technology could rapidly measure surfactant in COVID-19 patients,” said Povl Verder, CEO of SIME. “By coupling surfactant screening with targeted treatment strategies, we now have the ability to significantly improve the care of ARDS and COVID-19 ARDS patients.”
ARDS: Urgent Unmet Global Need
ARDS is a complex life-threatening condition caused by physical damage to the lung or infections such as sepsis, pneumonia and COVID-19. Of all respiratory viruses and bacteria, none are known to reduce surfactant as frequently, or severely, as COVID-19. Infection related ARDS (such as COVID-19 ARDS) causes severe inflammation of the lung in addition to surfactant deficiency, preventing adequate oxygenation of the blood. The disease accounts for 10.4% of total ICU admissions and 23.4% of patients requiring mechanical ventilation.6 Despite intensive treatment, ARDS has an extremely high mortality rate of 40%6 and is also associated with a significant economic burden: costing $108,000 – $158,000 in the US and $39,000 – $116,000 in Europe and Canada.7
SIME Clinical AI Platform
The patented AI platform consists of a compact cloud connected device and reagent-free disposable designed for point-of-care use in intensive care units. Enabling the prediction of acute respiratory diseases within 10 minutes from routinely collected samples.
References:
1. Schousboe, P et al. Reduced levels of pulmonary surfactant in COVID-19 ARDS. Sci Rep 12, 4040 (2022). https://doi.org/10.1038/s41598-022-07944-4.
2. Heiring, C et al. Predicting respiratory distress syndrome at birth using a fast test based on spectroscopy of gastric aspirates: 2. Clinical part. Acta Paediatr. 2020;109: 285-290. https://doi.org/10.1111/apa.14831.
3. Tzotzos, S.J et al. Incidence of ARDS and outcomes in hospitalized patients with COVID-19: a global literature survey. Crit Care 24. 2020;516. https://doi.org/10.1186/s13054-020-03240-7.
4. Schousboe, P et al. Assessment of pulmonary surfactant in COVID-19 patients. Crit Care 24. 2020;552. https://doi.org/10.1186/s13054-020-03268-9.
5. https://clinicaltrials.gov/ct2/show/NCT04609488.
6. Bellani, G et al. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016;315(8). doi:10.1001/jama.2016.0291.
7. Paul E, et al. The Cost of ARDS: A Systematic Review, Chest, V161, 2022, https://doi.org/10.1016/j.chest.2021.08.057.
