Platform applications


 

SETTING A NEW STANDARD OF NEONATAL RESPIRATORY CARE
PREVENTATIVE CARE FROM THE FIRST BREATH

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Platform applications


 

SETTING A NEW STANDARD OF NEONATAL RESPIRATORY CARE
PREVENTATIVE CARE FROM THE FIRST BREATH

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 A transformative approach to diagnostics

The Digital Molecular Diagnostics (DMDx) platform measures multiple biomarkers simultaneously, from a single sample, in real time at the point-of-care. A range of neonatal and maternal health products are currently in development, and the first product to market will be a Lung Maturity Test (LMT) for use in the Neonatal Intensive Care Unit (NICU).


 Neonatal point-of-care Lung Maturity Test (LMT) 

Photo by annedehaas/iStock / Getty Images

Respiratory Distress Syndrome (RDS) is an unmet clinical need

RDS, a breathing disorder caused by a lack of surfactant, it is the primary cause of mortality and severe morbidity in preterm babies. Today RDS is diagnosed a few hours after birth by accessing symptoms. Surfactant treatment is then administered, which slows, and eventually halts, disease progression. 

RDS can be prevented with early diagnosis and treatment

Surfactant therapy is highly effective, and if administered minutes after birth it has the potential to prevent RDS. So why not give it to all babies? A COCHRANE REVIEW found that prophylactic treatment can harm healthy babies, therefore an early diagnostic for identifying which babies are at risk of RDS is needed. 


The world's first rapid RDS diagnostic delivers precise results in minutes

Requiring only a small sample of gastric aspirate, fluid routinely extracted from the stomach at birth, SIME Dx can accurately predict RDS within minutes at the point-of-care. Enabling doctors to identify which babies are at risk of RDS and require preventative treatment. LMT is the first application on the neonatal and maternal health DMDx platform.  


LMT has been scientifically proven,
to predict RDS with HIGH sensitivity 

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 that need treatment, we can significantly improve RDS clinical outcomes, and potentially lessen the need for mechanical ventilation and oxygen.
— Henrik Verder, Christian Heiring, Howard Clark et al. ACTA Paediatrica 2016

Recent European Guidelines highlight the need for bedside RDS test

Methods to measure the presence or absence of endogenous surfactant, such as lamellar body count in gastric aspirate, may help in deciding whom to treat. However, methods that require laboratory expertise around the clock are unlikely to be widely adopted and a simple bedside test that can be used within the NICU is needed.
— David G. Sweet et al. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2016 Update, Neonataology 2017;111:107-125.

The development of the Lung Maturity Test (LMT) application is supported by EU Horizon 2020 Phase 2 SME Instrument (project no. 666668). 

Platform applications2


EXPANDING THE DMDx PLATFORM IN THE NICU
NEW NEONATAL AND MATERNAL
HEALTH PRODUCTS IN DEVELOPMENT

Platform applications2


EXPANDING THE DMDx PLATFORM IN THE NICU
NEW NEONATAL AND MATERNAL
HEALTH PRODUCTS IN DEVELOPMENT

More information coming soon.