Development of a multiplex assay for the identification of women at risk of preterm labour.

Funded Activity Summary

Preterm birth (ie birth before the 37th week of gestation) is the most significant problem facing contemporary clinical obstetrics in the developed world and occurs in approximately 5% to 12% of all deliveries. Being born too early is the major cause of perinatal morbidity and mortality. Data from Australia indicate that each year, more than 17,000 babies will be born prematurely. Of these infants, over 10,000 will suffer respiratory complications and about 1300 will die during the first 21 days of life. The sickest and most premature of these infants require admission to a Neonatal Intensive Care Unit in a tertiary hospital. Aside from the medical implications of premature delivery, there is also a considerable fiscal challenge to society. While treatments for the prevention of labour have improved considerably over the past decade, current screening tests of preterm labour (ie Fetal Fibronectin test) are unreliable and have poor positive predictive values. The principal objective of this project is to develop and deliver a multiplex assay for the prediction and diagnosis of human preterm labour. Through the successful application of our own proteomic discovery programmes using both ovine and human cervico-vaginal fluid samples, we have identified several new protein markers of labour. Having completed this Phase 1 biomarker trial and established proof-of-concept, we are now well positioned to initiate a Phase 2 biomarker trial to determine reliable estimates of assay sensitivity and specificity. This project targets the development of a new diagnostic to meet a recognised market gap. Delivery of such a test will create a new market in pregnancy-based clinical diagnostics and significantly impact on improving health care and quality of life for many preterm babies. Should the project be completed as detailed and mitigate some of the risk of commercial development, it would then be realistic to seek substantial funding from the private sector.

Funded Activity Details

Start Date: 01-01-2007

End Date: 01-01-2007

Funding Scheme: NHMRC Development Grants

Funding Amount: $202,350.00

Funder: National Health and Medical Research Council

Research Topics

ANZSRC Field of Research (FoR)

Medical Biotechnology Diagnostics (incl. Biosensors)

ANZSRC Socio-Economic Objective (SEO)

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Other Keywords

Biological Markers | Diagnostic Assay | Diagnostic Test | Early Detection and Intervention | Maternal and Child Health | Prediction | Preterm Delivery | Preterm Labour | Prevention of Prematurity | Proteome Analysis

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