Integrated company
The adoption of personalized medicine solutions by the medical community and in particular the integration of genomics into regular practice, will require demonstration of the proof of clinical utility.
Such demonstration is possible only if discovery, development and production of molecular assays are conducted in a fully integrated approach. This includes, in particular, expertise and capabilities for clinical development of personalized medicine solutions (assays and related therapeutics) from a regulatory perspective.
From exploration through to marketing, TcLand Expression has set up teams of experts for the identification, development and marketing of personalized medicine solutions in the aim of offering tools ready to be integrated into medical practice. TcLand expression’s workforce comprises:
- A team dedicated to Gene Expression Biomarker (GEB) identification and validation, including qualified biostatisticians and bioinformaticians.
- A team dedicated to clinical and regulatory development of our GEB . This team is responsible for running monitored prospective multicenter clinical trials, and obtaining US and EU approval of our GEB
- A team dedicated to the production of our test through a state-of-the-art central laboratory, dedicated to routine molecular biology analysis. Our central laboratory facility is ISO17025 accredited for qPCR gene expression tests.
- A team dedicated to obtaining reimbursement of our GEB from payers and market adhesion from prescribers.
A fully integrated development, production and marketing approach:
