AKESOgen provides highly standardized development and application of clinical biomarkers for the international pharmaceutical and diagnostic industry. AKESOgen has an expert team of pathologists to draw on who operate in a professional environment of project management, logistics, data and quality management. AKESOgen also supports the introduction of new Companion Diagnostic assays into the market.
AKESOgen provides premier biomarker services in clinical trials under GLP/GCP conditions for top tier international pharmaceutical and diagnostic companies.
In the companies’ state-of the art laboratory facilities, in addition to basic pathology services such as slide reading, annotations, cytogenetics etc new molecular techniques to analyze biomarkers such as qPCR, expression profiling, methylation analysis and Next Generation Sequencing are established. New assays are also added and validated constantly upon demand.
AKESOgen’s Molecular Pathology services supports global clinical trials with pathology services through board certified pathologists, project management through PhD trained managers, logistics (e.g., sample kits, sample pick-up, re-shipment, storage, archiving), data/quality management, assay development, consulting and training according to full GLP/GCP standards. AKESOgen is regularly audited by our customers.
Companion diagnostics (CDx) have emerged as a critical tool for the identification of patient sub-groups for personalized drug treatment. In conjunction with targeted drug development, CDx offer companies greater efficacy, accelerated regulatory approval and better reimbursement.
CDx have become an integral part of the clinical development process. When data on the predictive value of a biomarker are available, a drug cannot be approved without CDx. The example of Trastuzumab (Herceptin®) from Roche and the corresponding companion diagnostic HercepTest™ from Dako for the treatment of breast and stomach cancer were the first examples to demonstrate the predictive power of CDx in targeted patient treatment.
CDx development is a complex process. It involves an understanding of pharmaceutical company resources; diagnostic company goals; FDA regulatory requirements; clinical trial processes and the clinical goals of physicians amongst others.
AKESOgen has all the expertise to support the above processes.
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