Personalised medicine may be seen as the tailoring of medical treatment to the individual needs of a patient during all stages of care including prevention, diagnosis, treatment and follow-up.
Biomarkers for companion diagnostics can assist with drug selection by providing "the right patient with the right drug in the right dose at the right time" and thereby add competitive value to a drug.
However, despite numerous scientific publications on predictive biomarkers, FDA (the US Food and Drug Agency) has approved only 20 biomarkers for selection of patient treatment. Nineteen are from the field of oncology. The list is limited to eight different biomarkers from 11 different companies. To improve patient benefits of a treatment, the medical and clinical need for biomarkers must be met. Biomarkers outside the field of oncology are scarce and a leaner biomarker discovery phase can optimise biomarker and drug development.
An objective biomarker selection phase is part of true biomarker discovery and should ideally start very early in parallel with drug discovery. The regulatory process must be addressed at an early stage of development, as it will influence the later stages of companion diagnostic development. A variety of parameters will influence the performance of the assay, e.g., scoring criteria, cut-off values, patient populations and treatment regimens. Development costs, assay availability, reimbursements and other economic aspects should be considered at an early stage of the assay development.
Danish Technological Institute can provide:
- Independent and objective guidance on biomarker development
- Target selection and assay validation for companion diagnostics
- Profound literature search to establish the biological rationale of the biomarker
- Expertise within proteomics, genomics, PCR, FISH, immunoassays and phage display
- Objective comparison of different techniques and assay protocols
- No preconceived biomarker or platform preference
- Expertise in regulatory approval (FDA approval and CE labelling)
- Guide on performance characteristics related to safety and effectiveness
- Guidance fee-for-service or as part of R&D projects