Yet, only 1 % of the pharmaceuticals available on the market are offered in combination with a biomarker-based therapy accompanying diagnostics (Companion Diagnostics) regarding efficacy, safety or metabolization of the drug. However, 60% of the pre-clinical pharmaceuticals and 50% of the phase I candidates are developed together with a diagnostics (status 2013). Moreover, regulatory authorities such as the US-American Food and Drug Administration (FDA) prefer a stratification of patients in early stages of drug development.
Companion Diagnostics are applied in order to
- to predict whether a given therapy is promising
- to define patient subgroups
- to diagnose diseases at an early stage
- to carry out pharmaceutical development faster and promising
The Companion Diagnostics Network develops, manufactures and distributes in-vitro diagnostics
- for pharmaceuticals in pre-clinical and clinical development
- for pharmaceuticals that are already on the market
- for pharmaceuticals that have failed approval
The fields of application comprise
- Allergy Diagnostics
- Endokrinology & Metabolism
- Human Genetics
- Neurodegenerative Diseases
- Prenatal Diagnostics
The portfolio encompasses diagnostic technologies and methods for areas such as
- Cell-based Assays
Moreover we offer accompanying services to conduct clinical diagnostic studies and sevices in the area of software development and software connection. Consulting services concerning certification, reimbursement and patent law complete the business activities of the Companion Diagnostics Network.
Active support by the network management
For the whole duration of the project there is one contact person available that deals with all costumers’ requests.
If desired, the network management carries out the following tasks
- Confidential acquisition of the customer’s request
- Composition of the project teams
- Project and interface management
- Continuous reports of the project’s progress
- Organization of the communication between customers and project partners if required, e.g. business meetings & teleconferences)
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