Strategy

DiaGenic’s mission is to offer patient friendly diagnostic tools for the early detection of diseases, thereby leading to improved quality of life.
DiaGenic is the first to market with blood based diagnostic tests for Alzheimer's and Breast Cancer. DiaGenic's vision is to become a leader in the development of tests for the early detection of diseases through the analysis of gene expression in blood. DiaGenic's diagnostic approach is widely applicable and will be further developed for use in the diagnosis of many other serious diseases. The company takes product candidates from exploratory research through the entire product development cycle up to the establishment of sales and marketing channels for its tests. DiaGenic's concept of performing gene expression analysis on peripheral blood samples is central to the company's patent strategy. DiaGenic seeks to build up a patent portfolio that secures good protection of its products within the diagnostic use of gene expression in blood samples.
Sales and marketing is undertaken in co-operation with different partners. These commercial partners have been selected based on their local market access, competence and product profiles. DiaGenic's new IVD tests represent a novel concept within the field of clinical diagnostics. Therefore, the company envisages a gradual market entry process that takes into account regulatory requirements, market sizes and reimbursement schemes. DiaGenic is currently building the necessary sales channels throughout Europe for both the breast cancer test, (BCtect®) and the Alzheimer's test (ADtect®). DiaGenic's primary focus will be selected markets in Europe followed by entry into other attractive markets outside Europe. DiaGenic's strategy for entering the US market is currently in preparation with the aim of FDA approval of our tests. The strategy involves several university hospitals, CLIA laboratories and marketing/sales partners for commercialization.
BCtect® and ADtect® are both based on a new and unique diagnostic concept. The initial phase following the product launch is to build confidence in the product through scientific marketing in order to achieve widespread acceptance.
DiaGenic is focusing on two different segments in the market: MDx - molecular diagnostics and Rx - biomarkers for the pharmaceutical industry.
MDx - Molecular diagnostics
Development of regulatory approved tests for medical diagnosis is a core focus area and embedded in DiaGenic's IP. We are conducting multicentre studies in Europe and the US, where we have access to high quality blood samples from well characterized patients and controls.. DiaGenic will work together with partners in the individual markets for the sale and marketing of the CE marked products ADtect® and BCtect®. Initial focus will be directed towards memory clinics and neurologists for ADtect® and gynecologists and radiologists for BCtect®.
Rx - Biomarkers for the pharmaceutical industry
DiaGenic is in a leading position with regard to the identification of gene expression biomarkers in blood for the early diagnosis of Alzheimer's and Parkinson's disease. However, the development of biomarkers for use in connection with drug development is an important business segment for DiaGenic. The scientific expertise, development knowledge and patent rights held at DiaGenic can provide valuable support to pharmaceutical companies in their drug development programs. The CE marked ADtect® can ensure a more homogenous study population in clinical trials for Alzheimer's, thus saving costs and improving success rates. DiaGenic has already signed an option contract for biomarker development with the first pharmaceutical company, Merz Pharmaceuticals GmbH, in June 2009 for developing a test that can identify which subjects with mild cognitive impairment (MCI) are more likely to convert to Alzheimer's disease.
