Lung Maturity Diagnostic Device

Today SIME Dx, a digital molecular medicine company focused on the development and commercialization of point-of-care (POC) diagnostics, announced a new device design that fully automates the company’s novel neonatal Lung Maturity Test (LMT). LMT, the first application on the patented Digital Molecular Diagnostics (DMDx) platform, has been clinically proven to predict Respiratory Distress Syndrome (RDS) with high accuracy. RDS is the leading cause of morbidity and mortality in premature babies, and can only be prevented with early diagnosis and targeted treatment.

LMT addresses this urgent unmet clinical need in the Neonatal Intensive Care Unit (NICU), where speed is critical and rapid screening has the potential to change the standard of care. To achieve real-time, lab-quality diagnostic results within minutes, SIME Dx developed an automated digital platform – DMDx. Powered by photonics and machine learning, DMDx measures multiple biomarkers simultaneously, in real-time, without the use of reagents or laboratory expertise. This transformative approach to diagnostics is ideal for POC and offers considerable advantages over central laboratory testing, such as fast and simple sample handling, early diagnosis and preventative care.

To develop the LMT device, SIME Dx partnered with Integrated Technologies Limited (ITL), an award winning and innovative medical device design house and manufacturing group based in England, the United States and China.

“Completion of the LMT device design is a major milestone for SIME Dx. For the first time we are able to demonstrate exactly how our technology translates into a viable point-of-care product.” said Povl Verder, CEO of SIME Dx. “The focus is now on performance testing the device in a programme of clinical work in NICUs across Europe and China, as the company prepares for regulatory approval and early commercialization.”

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