Digital molecular medicine company SIME Dx has announced the validation of its lung maturity test (LMT) to identify infants at risk of respiratory distress syndrome (RDS) who could benefit from early surfactant treatment.
The method was validated by comparing RDS risk predictions to actual incidences of RDS in patient samples collected in Denmark, Sweden and the UK.
The LMT is performed on small volumes of gastric fluid derived suctioned as part of the routine management of neonates at birth.
It then makes an infra-red spectroscopic analysis of this gastric fluid, using a specially developed machine learning algorithm to determine the lecithin-sphingomyelin (L/S) ratio in the sample which are biological constituents found naturally in the lungs.
A low L/S ratio denotes high risk of RDS.
RDS accounts being the major cause of mortality and morbidity in premature infants that can be treated with surfactant, a therapy reducing the effort needed to expand the lungs during inspiration and allow gas exchange to take place.
Lead inventor of the test Professor Henrik Verder said: “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 RDS.”