Using Primary Human Cells to Discover and Validate Companion Diagnostics

Companion diagnostics is a term used to describe tests which assess whether a treatment is likely to be safe or effective. They can be used to identify patients that have the greatest chance of benefiting from the treatment, or those that have a low likelihood of succumbing to adverse side effects. Companion diagnostics can also be used to find the right dose levels for a particular individual.

For several therapy areas, the development of new therapeutics is accompanied by the development of its companion diagnostic. This has been particularly true of cancer drug development, but other disease areas are catching up; particularly when the treatment options include drugs that have potential toxic side effects. These companion diagnostics have the potential to reduce the costs of clinical trials and the risk of trial failure because they identify patient groups that will respond well to the new drug even before it has been administered. Once the drug is marketed, the companion diagnostic will help lower treatments costs by targeting therapy to those who will benefit from it; so-called “personalised medicine”.

Identifying and validating highly predictive biomarkers that can be easily measured in a clinical setting is a major challenge in clinical diagnostics. CellMade’s primary human cells and CellInsight™ advanced 3D cell co-culture models, coupled to real-time lipid profiling bioanalytics, offer the perfect platform for efficient discovery and validation of companion diagnostics. We can simulate the inflammatory process on healthy cells and compare their lipid profiles with and without the addition of the test drug candidate. Alternatively, we can assess the effects of drug treatment on patient vs healthy cells.

Major benefits of CellMade’s approach include:

Use of primary human cells which more faithfully represent the in vivo situation, compared to cell cultures or animal models.

Measurement of lipid profiles which can be performed on peripheral clinical samples such as skin patch tests, blood or even tears, making it feasible in a clinical setting.

Established cell/tissue acquisition clinical networks and protocols to ensure data quality and reliability.

If you’re interested in establishing a companion diagnostic for your drug development program, please contact us to discuss how we can help.