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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - IPOG (Improving Pregnancy Outcomes Gloablly)

Teaser

Summary

Global Health Problem:
One of the most significant complications which can occur during pregnancy is Preeclampsia, affecting up to 8% of all pregnancies. Unfortunately, the disease is complex and remains hidden in early pregnancy. When clinical symptoms do eventually appear, preeclampsia can have serious health implications: the condition is responsible for the deaths of more than 70,000 mothers and half a million babies each year.

In addition to the human cost, dealing with preeclampsia puts significant pressure on healthcare systems worldwide. Identifying in early pregnancy, those mothers at risk of developing preeclampsia is difficult. The current gold standard in prenatal care does not detect the disease early enough, thus limiting the opportunity for medical interventions. If clinicians could easily identify early in pregnancy those at risk of the condition, there is clinical intervention available which can have a dramatic impact, saving the lives of mothers and babies.

Metabolomic Diagnostic\'s (METABOL) Solution:
METABOL has developed PrePsiaâ„¢, a novel early pregnancy screening test for Preterm Preeclampsia with a detection rate significantly greater than current clinical practice. METABOL developed PrePsiaâ„¢ a simple blood test which will enable clinicians, with a simple blood test, to personalise pregnancy care, including the initiation of treatments in early pregnancy that can dramatically reduce the incidence of Preterm PE.

PrePsiaâ„¢ is a simple blood test taken early in pregnancy, this blood sample is then tested in a clinical laboratory on a Liquid Chromatography Mass Spectrometer platform (LC/MS) which has been shown to be a cost-effective solution in the clinical laboratory.

Importance for society:
The accelerated commercialisation of PrePsiaâ„¢ through the support of Horizon2020 will save the lives of mothers and babies and generate cost savings for health services globally. In the EU, with about 5.1 million births per annum (2015 data), treating the women identified at high risk for preterm PE by PrePsiaâ„¢ has the potential to prevent over 37,000 cases of Preterm PE and its associated severe outcomes, every year.

Metabolomic Diagnostic\'s Vision:
METABOLâ€™s vision is to make pregnancy safer by identifying early in a womanâ€™s pregnancy, her risk of developing complications later in her pregnancy.
To enable this, the company has developed techniques through which the analysis of one blood sample using Mass Spectrometry in the clinical lab will inform the clinician of the risk to mother and unborn child of a range of pregnancy complications.
PrePsiaâ„¢ is the first of METABOLâ€™s pipeline to be commercialised.

Overall Objective:
IPOG funding is supporting METABOL in launching PrePsiaâ„¢ in its first 10 target geographies and establishing significant revenues million and in generating employment for 50 people by year 4. IPOG will support METABOL in fulfilling its ambition to become a world leader in innovative pregnancy diagnostics and cement its position as a global leader in translational research.

Work performed

Work performed in IPOG period November 2018 up to and including October 2019:
The first 12 months of IPOG have been very exciting and demanding. In the 12 months the main results achieved so far which will support the overall project objective of launching PrePsiaâ„¢ in the marketplace are as follows:
â€¢ Commercial Engagement: IPOG facilitated the recruitment of an experienced Medical Devices Marketing professional which has boosted our presence in the market, engaging with clinicians, clinical laboratories and advocacy groups. Our Marketing Manager, with her prior experience of commercialising medical diagnostics products has helped focus the teams commercial activities to the most appropriate channels. The team have been working to develop our existing relationships while also adding new contacts to our network. This element has been crucial in delivering back significant commercial information to our development team to support the launch of the product that is best placed to meet user needs.

â€¢ Dissemination and Communication: For the uptake of PrePsiaâ„¢ in the market, METABOL needs to communicate effectively with the different stakeholders. There are key fields of stakeholders that we need to engage with; Patients, Clinicians, Commercial Laboratories, Diagnostic Platform Companies (LC/MS), Healthcare Payers, Regulators and Investors. METABOL has been very active in engaging with the market. Within the new expanded team, we have a new Scientific Writer and Researcher who is responsible for delivering dissemination content to the marketplace. We published our first white paper and have submitted a scientific paper which is currently subject to peer review. In addition, METBOL had two posters accepted for presentation at key European conferences; the 66th Annual Scientific Meeting, Society for Reproductive Investigation 2019 and the Mass Spectrometry Applications in the Clinical Lab 2019 EU.

â€¢ Commercial Clinical Laboratory environment for running PrePsiaâ„¢: Significant commercial and regulatory engagement has shown us that our initial assumptions were somewhat misplaced. Our engagement with the market indicated that the infrastructure required to run our test is already in place in a number of clinical laboratories in key geographies and our planned investment in our own laboratory infrastructure did not make commercial sense. The existence in clinical laboratories of the necessary LC/MS platform to run our innovative test is a significant boost to our commercial engagement plans and removes one of the key barriers that we had anticipated.

â€¢ Engagement with non-EU bio-banked sample collections: The interest from the global market has continued to gain pace. As we have engaged with the market to investigate the availability of non-Eu bio banked samples collections (cohorts) we have been overwhelmed by the positive engagement and significant interest in PrePsiaâ„¢ from global clinicians.

â€¢ PrePsiaâ„¢ laboratory workflow: Our new Development manager is working closely with the development team to refine the laboratory workflow to bring it into line with standard commercial workflows in the IVD marketplace. Initial work on this area has demonstrated that we can deliver a significantly higher test throughout than had originally assumed. Doubling the test throughput is a very significant commercial factor supporting the adoption of the test in commercial clinical laboratories.

Final results

The current state of the art for the risk prediction of preterm Pre-eclampsia is typically risk factor checklists. Example risk factors include, high BMI, high blood pressure, preeclampsia in previous pregnancy. If women have some of these risk factors they are classed as â€˜at riskâ€™. However many women without overt risk factors will also go on to develop pre-eclampsia and there is currently no way of identifying that they are at risk. PrePsiaâ„¢ is a simple blood test which will identify those at risk, with a significantly increased detection level to what is possible with current clinical practice.
The impacts are that more women will be correctly identified as at risk and will get the appropriate clinician intervention thus reducing significantly the bad outcomes for mothers and babies typically associated with preeclampsia.