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PreEclampsia diagnosis by Early Kidney Injury Detection

Periodic Reporting for period 1 - PREKIND (PreEclampsia diagnosis by Early Kidney Injury Detection)

Berichtszeitraum: 2015-05-01 bis 2015-07-31

Health Challenge:
PreEclampsia (PE) claims the lives of 75,000 women annually and the 6,000,000+ surviving mothers will have an increased risk of cardiovascular disease for the rest of their life. PE accounts for over 500,000 infant deaths worldwide every ; and for the millions of babies that survive, they too will go on to have increased risk of a variety of health issues. PE is a syndrome that develops during pregnancy but presents no clinical symptoms during most of the pregnancy and is therefore currently complex to diagnose.
Business Challenge:
With an annual spend of over 31Billion 2 in direct costs in the developed world alone, the provision of antenatal care to pregnant women has a significant impact on health care budgets; dealing with the immediate consequences of PE form an important contribution to this cost. The Preelampsia foundation (http://www.preeclampsia.org/) estimates the annual cost of PE is more than $7billion in the US.
InformBio Business Innovation:
InformBio (IB) has licensed pioneering research by Dr.Vesna Garovic of the Mayo Clinic, USA. The technology has identified podocyte specific biomarkers in urine that indicate ongoing renal damage and which allow for a subclinical diagnosis for PE. The key biomarker, podocin, has demonstrated exceptional sensitivity and specificity and can diagnose the disease up to 3 months before clinical symptoms emerge. InformBio are currently working to develop flow cytometry and research use only (RUO) ELISA assays for the biomarker.
Phase 1 feasibility:
The feasibility study was to support the development of a detailed business plan for the introduction of a PE diagnostic test.
Objectives of Phase I feasibility study:
1) Service Delivery Model; Gather additional data on service delivery models in key target markets.
2) Reimbursement; To understand the likely reimbursement models in key target markets of EU and US.
3) Cohorts; To identify partners and estimate costs for the recruitment of cohorts for further clinical validation.
4) Health Economics; Preliminary health economics report outlining the most significant financial benefits.
5) Regulatory: Formulate a regulatory strategy for the introduction of the test in key geographies.
6) Business Plan: A business plan incorporating the learning from the feasibility work.
Service Delivery Model: InformBio appointed reputable consulting firm to research a Go to Market Strategy for the IB test. The scope was to identify the priority markets for InformBio’s pre-eclampsia test, and within those markets to identify early adopter reference laboratories/hospitals for the technology. In addition Inform Bio initiated discussions with some major future potential collaborators in the space to gain further insight into the practicalities of the target market.

Reimbursement: Reimbursements strategies in the target geography's were also considered as part of the analysis on the most appropriate target markets.

Cohorts: Identification of existing cohorts and potential cohort recruitment partner cohorts was completed as part of the feasibility. A first draft clinical study protocol was issued.

Health Economic: A customized report was commissioned on the preliminary Health economics of the Inform Bio test when it is introduced to the market based on current market conditions and current Inform Bio test status.

Regulatory: As part of the Service delivery model work completed, the regulatory landscape in target markets was also considered.

Business Plan: The work carried out has contributed significantly to the draft Inform Bioscience Business Plan which will form part of the PHASE 2 Application
The expected final results is the deployment of a Pre-eclampsia diagnostic to the global market. The expected impact will be better patient outcomes and cost savings to health care services. The impact for the SME will be its further development as an innovative sustainable business with resources and knowledge that can also be utilized on other diagnostic innovations.
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