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/(si apre in una nuova finestra)) 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.
