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Combined Biomarker and Drug Development

We were recently asked by one of our customers if our products could serve as a platform to develop companion diagnostics during drug testing.

Plexision performs custom R and D projects aimed at integrating biomarker targets in all phases of drug development, from preclinical to post-marketing.

A range of antigen-specific and non-specific cell-based assays can be adapted for immunological drug development services in the following categories:

  • Predicting effective concentrations of single and multiple-drug regimens.
  • Design and development of cell-based companion diagnostics.
  • Surrogate endpoint development.
  • Assay validation and performance assessment.

Plexision can also assist drug developers in regulatory submissions for biomarker qualification.

If you would like to know more about our research capabilities, please contact us at drugs@plexision.com.

Technology - How It Works

Traditional tests for immunologic diseases measure disease activity with non-specific injury markers, markers of fully evolved injury, or by measuring the disease agent itself. A need exists to predict whether immunological disease will occur with tests which are highly specific for that disease.

Personalized risk assessment

Because of wide individual variation in immune response, thresholds of disease-risk or disease severity are unlikely to be the same in any two individuals. Therefore, predicting disease-risk in individuals can be difficult with traditional tests. Disease-risk assessment may be most useful when it is specific to an individual, and can be compared over time in that individual.

Advantages of cell-based assays

Personalized disease-risk assessment with cellular biomarkers utilizes inherent attributes of cells.

  • Cells represent the first living unit to recognize potentially harmful foreign substances.
  • Cells are also the first living unit to respond, recruit other cells to respond, or retain memory to facilitate future inflammatory responses.
  • Plexision's cellular assays simulate disease, and generate test outputs, which are normalized to the individual, enabling personalized disease-risk assessment.