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Development of a digital diagnostics rapid Lung Maturity Test (LMT) for premature infants, to assist neonatologists in the diagnosis of Respiratory Distress Syndrome at birth

Objective

SIME LMT will develop a simple digital, software and cloud-based diagnostic test to analyse very small samples of bodily fluid at point of care that predicts the risk of an infant developing Respiratory Distress Syndrome (RDS) within 10 minutes of birth. The platform will offer neonatologists more control through greater accuracy and faster results so they can deliver optimal patient care and improve clinical outcomes. Such technology has not been deployed before in healthcare diagnostics because of the complexity of the required knowledge and expertise in the field of chemometrics. RDS can only be prevented by a quick diagnosis of lung maturity and treatment at birth.

We have developed a working prototype test that measures within 95% of the established laboratory and chemistry validation methods. We are currently refining the method in a pre-clinical test which will provide test validation data and demonstrate that the test improves clinical outcomes and enables change in clinical practice from the current treatment standard to a preventative treatment protocol which reduces RDS i.e. generating Level 4 – Level 1 evidence.

Our initial target market is the NICUs: 2000 in the US and 1,400 in the EU, where there is an estimated market of 916,000 tests and a revenue potential of approx. €375m per annum. SIME Diagnostics also has the potential to reduce neonatal intensive care treatment including mechanical ventilation by 60%, less time on oxygen and hospital stay by 10 days. The overall savings opportunity has been estimated to be more than €3.4bn total, and €1.5m per 100 cases representing a cost savings and profit making opportunity for healthcare providers worldwide. The project is well aligned with our business growth strategy which is aimed at growing the business through digitising biological information, driving innovation in life sciences and healthcare. Attaining level 1 clinical evidence will increase company valuation to >€60m.

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Programme(s)

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Topic(s)

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Funding Scheme

Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.

SME-2 - SME instrument phase 2

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Call for proposal

Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.

(opens in new window) H2020-SMEInst-2014-2015

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Coordinator

SIME DIAGNOSTICS LIMITED
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 2 864 455,50
Address
Stevenage Bioscience Catalyst, Gunnel Wood Road
SG1 2FX STEVENAGE
United Kingdom

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
East of England Bedfordshire and Hertfordshire Hertfordshire
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Links
Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 3 417 674,90
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