Personalized medicine is evolving diagnostics which help tailor treatments to the individual patient. Certain tests help determine which patients would benefit from a particular therapeutic or, conversely, which patients should not receive the treatment. These tests are called companion diagnostics (CDx).
The companion diagnostic is essential to the safe and effective use of the therapeutic. Because the companion diagnostic test is designed to be paired with a specific drug, the development of both products requires close collaboration in the clinical trial development process. ApoCell’s integrated approach to platform technologies, along with its deep clinical trial experience makes the company an ideal partner in the development of new companion diagnostics.
ApoCell collaborates with clients to co-develop assays based on biomarkers used in clinical translational research. In some trials of targeted agents, positive correlation between biomarker expression and clinical outcome has been demonstrated, forming the basis for IVD and laboratory-based test development. ApoCell is very experienced in developing and using sensitive and specific blood-based and tissue-based assays of target expression in various sample types for clinical trials. This proven methodology can be adapted to diagnostic, prognostic and monitoring tests.