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Improving Pregnancy Outcomes Gloablly

Periodic Reporting for period 2 - IPOG (Improving Pregnancy Outcomes Gloablly)

Reporting period: 2019-11-01 to 2021-01-31

METABOL is a deep-tech company specialized in the development of novel biomarker-based diagnostic solutions for complex diseases. The company has developed an effective pipeline to firstly identify diagnostic biomarker panels and then translate these panels into clinical assays ready for application in the clinical laboratory.
This pipeline combines the biomarker multiplexing capabilities of Mass Spectrometry (LC-MSMS), a powerful analytical technology, with the company’s own informatics and statistics solutions to deliver diagnostic innovation. This is reflected in METABOL’ strong and versatile IP portfolio of technical innovations and biomarkers.
We use LC-MSMS to evaluate multiple biomarker candidates in one run, leveraging the multiplexing capabilities of LC-MSMS platforms. Thus facilitating translation to novel IVD suited for risk screening in the clinical laboratory.
Our technology combines the biomarker multiplexing capabilities of Mass Spectrometry with the company’s own informatics and statistics solutions to deliver diagnostic innovation.
METABOL vision is to develop a portfolio of diagnostic solutions for pregnancy risk for the “great obstetrical syndromes”. These are complications of pregnancy that arise when the complex and highly concerted interactions formed in pregnancy between mother, baby and the environment are disturbed in some way. This can lead to pregnancy complications like preeclampsia, gestational diabetes, preterm birth, and in-uterine growth restriction, which all have the potential to severely impact on the well-being of mother and child.
In collaboration with leading clinical researchers worldwide, METABOL’ team have used mass spectrometry based workflows to analyse 1000’s of pregnancy samples, which allows us to verify a panel of biomarkers relevant for the prediction of preeclampsia risk. Our team is already working on similar solutions for some of the other great obstetrical syndromes.
IPOG supported METABOL in its journey to become a world leader in innovative pregnancy diagnostics by supporting the development of METABOL's first product PrePsia™ . Pregnancy care globally has not benefited from recent significant advances in technology, IPOG has supported METABOL to change that. The accelerated commercialisation of PrePsia™ through the support of Horizon2020 will save the lives of mothers and babies and generate cost savings for health services globally.
PrePsia is a prototype screening test, which identifies in early pregnancy, those women at increased risk of developing preeclampsia later in their pregnancies
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.

PrePsia™ will revolutionise prenatal care globally by enabling healthcare providers to customize pregnancy care to a woman’s personal risk profile.
PrePsia™ is a simple blood test that will run in clinical laboratories on Liquid Chromatography Mass Spectrometer platforms (LC/MSMS) which has been shown to be a cost-effective solution in the clinical laboratory.
METABOL will change pregnancy care globally and impact on a field of medicine that has largely gone unchanged in 100 years. IPOG has bought METABOL closer to achieving that mission and provided us with greater insights into the world of innovation in medicine. IPOG has supported us in engaging with the stakeholders that are key to success, it has facilitated us in generating commercially significant laboratory workflows, building a work class globally renowned team of scientist and innovators. We successfully progressed the technology through TRL 7 and currently we are finalising TRL8. IPOG gave us to opportunity to incorporate stakeholder feedback into our product to make the product more market appropriate and ensure we deliver the most impactful product to the market. METABOL's vision continues to be offering a range of tests to the pregnancy market, whereby the analysis of one blood sample will inform the clinician of the risk to mother and unborn child of a range of pregnancy complications. We are now even more committed and determined in this mission as during the period of IPOG the need for change in pregnancy care has been reinforced. METABOl are committed to ensuring that one of the most fundamental experience of life is made safer for mother and baby.

• PrePsia™ laboratory workflow: The ability to double our test throughput is a very significant commercial factor achieved during IPOG which will support the adoption of the test in commercial clinical laboratories.
• Engagement with non-EU bio-banked sample collections: We have been overwhelmed by the positive engagement and significant interest in PrePsia™ from global clinicians and were successful in securing access to a US and
Canadian bio banked samples collections (cohorts).
• Commercial Engagement: IPOG facilitated engagement in the market, engaging with clinicians, clinical laboratories and advocacy groups. The team worked on developing 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 ensure the voice of the customer is incorporated into the product. It will ensure
that PrePsia™ is best placed to meet user needs.
• Dissemination and Communication: For the uptake of PrePsia™ in the market, METABOL communicated 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/MSMS), Healthcare Payers, Regulators and Investors.
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 ‘at risk’. However many women without overt risk factors will also go on to develop pre-eclampsia and there is currently no other widely adopted way of identifying that they are at risk. PrePsia™ 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.