Foundation of Our Science
Metabolic profiling is a powerful strategy for investigating the low molecular weight (bio)chemicals (metabolites) present in the metabolome of a cell, tissue, or organism. Its position as the final downstream product of gene expression enables the provision of a high-resolution multifactorial phenotypic signature of causes, manifestations, and pathways of disease.
Professor Louise Kenny (University College Cork) and Professor Phil Baker (University of Auckland) have pioneered the clinical exploitation of metabolomic technology for patient benefit. A decade-long collaboration funded by the British Heart Foundation, Science FoundationIrelandand the Wellcome Trust has led to the discovery of a unique set of metabolites which can accurately predict pre-eclampsia based on a blood sample taken at 15 weeks.
In the development of realistic screening strategies, Metabolomic Diagnostics has several major advantages over other research technologies.
The research is based on samples from the SCreening fOr Pregnancy Endpoints (SCOPE) study (www.scopestudy.net) bio-bank. The SCOPE bio-bank includes almost 6,000 participants in 6 countries and almost 950,000 specimens. SCOPE is a prospective, cohort study. All samples are curated to FDA compliant standards, are accompanied by comprehensive metadata, and are well matched to avoid potential sources of bias. This is the foremost pregnancy related bio-bank in existence, and underpins the high quality of this research.
This predictive test has high sensitivity and specificity for discriminating between pre-eclampsia and other maternal disorders. In contrast to other potential technologies such as the detection of angiogenic factors, our test works in early pregnancy at a fixed time point when risk stratification would be most beneficial for ongoing management and intervention.
A PCT patent application for ‘The detection of risk of pre-eclampsia’ was filed in December 2010. The patent application includes 14 metabolites as individual prognostic variables, and makes claims to combinations of key metabolites. It is anticipated that other potential patents may be forthcoming for technologies surrounding different testing platform technologies associated with the 14 metabolites.
Metabolomic Diagnostics Ltd is currently collaborating with UCC on the further research, development and validation of a clinically useful early pregnancy screening test for pre-eclampsia, based on a combination of these metabolomic biomarkers and certain clinical risk factors. Our research to date is extremely encouraging and initial results are very promising.
A clinically useful platform for delivering the test needs to be capable of high throughput (420,000 /year (UK), 2,200,000/year (USA), and 10,000,000/year (China), the ability to measure a wide dynamic range of chemically labile metabolites, and have widespread availability. We are thus researching alternate platforms to analyze the metabolites and therefore facilitate scaling up of the test.
While initial work has focused on pre-eclampsia, our technology has the potential to screen for a range of complications of pregnancy. Our ongoing research will seek to develop a full panel of tests which will enable each woman’s prenatal care, to be tailored to her specific risk profile.