Data for a Rapid Lung Maturity Test Published in ACTA Paediatrica

Recently Published European Consensus Guidelines Highlight the Need for a Bedside TestNovember 28, 2016 03:30 AM Eastern Standard Time

LONDON–(BUSINESS WIRE)–SIME Dx, a digital molecular medicine company developing point-of-care diagnostics, announced data validating the efficacy of a lung maturity test (LMT) in identifying infants at risk of respiratory distress syndrome (RDS) who could benefit from early surfactant treatment. RDS is a major cause of mortality and morbidity in premature infants. It can be effectively treated with surfactant, a therapy which reduces the effort needed to expand the lungs during inspiration and allow gas exchange to take place. Early surfactant treatment can help prevent the onset and impact of RDS, however, prophylactic treatment has been shown to be harmful and only necessary in half of all pre-term infants. The LMT could allow screening of all pre-term infants for RDS risk. The study, published online by ACTA Paediatrica, is titled “Rapid determination of lung maturity in premature infants at birth by mid-infrared spectroscopy”[doi:10.1111/apa.13683].

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“This lung maturity test has been developed to identify pre-term infants who will benefit from early surfactant treatment. By only rapidly intervening in those infants who need treatment, we can significantly improve RDS clinical outcomes, and potentially lessen the need for mechanical ventilation and oxygen. The need for such a test has been highlighted in the recently published European Consensus Guidelines on the Management of RDS1,” explained Prof. Henrik Verder, Department of Pediatrics, Holbaek University Hospital in Denmark, lead author of the paper and inventor of the test. “Surfactant treatment itself is very safe and effective, however, there are risks associated with the intubation required for administration. This poses the question of whether the risks of prophylactic surfactant outweigh the benefits when some infants do not need treatment.”

The LMT is performed on small volumes of gastric fluid (aspirate) suctioned as part of the routine management of neonates at birth. Infra-red spectroscopic analysis of this gastric fluid, using a specially developed machine learning algorithm, determines the lecithin-sphingomyelin (L/S) ratio in the sample. These are biological constituents found naturally in the lungs. A low ratio indicates a high risk of RDS. This method was validated by comparing RDS risk predictions to actual incidences of RDS in patient samples collected in Denmark, Sweden and the UK.

“The development of our lung maturity test is the culmination of many years’ commitment and hard work by several collaborators. It is the first test resulting from our digital molecular diagnostics (DMDx) platform, which is able to measure multiple biomarkers from a single fluid sample, delivering real-time results to clinicians,” stated Povl Verder, CEO of SIME Dx. “We are currently developing a bedside version of the test for use in a clinical setting. This will enable us to validate the test and collect the necessary data for commercialisation. Furthermore, the company is expanding the (DMDx) platform to apply cloud-based machine learning, so that in the future the data captured can be analysed to improve algorithms and develop new test.”

This study was funded by the EU Horizon2020 Phase II SME instrument, project number 666668.

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