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Predicting cytomegalovirus viremia….with CMV-specific T-cells

Predicting cytomegalovirus viremia after liver or intestine transplantation (LTx, ITx) with CMV-specific T-cell subsets

Predicting Cellular Rejection With a Cell-Based Assay: Preclinical Evaluation in Children

Allospecific CD154+T-cytotoxic memory cells (CD154+TcM) predict acute cellular rejection after liver transplantation (LTx) or intestine transplantation (ITx) in small cohorts of children and can enhance immunosuppression management, but await validation and clinical implementation.
To establish safety and probable benefit, CD154+TcM were measured in cryopreserved samples from 214 children younger than 21 years (National Clinical Trial 1163578).

Prognostic cell-based assay predicts acute cellular rejection in pre- and post-transplant testing of children with liver and intestine transplantation (LTx, ITx).

Below is an extract of the original abstract from the Liver Meeting help in Washington DC.© The American Association for the Study of Liver Diseases. Original abstracts could be accessed via their site here

Plexision's PK/PD solutions presented at CHI's Immunogenicity Summit in Washington, DC - November 11, 2013.

Plexision’s Pharmacokinetics (PK)/Pharmacodynamics (PD) solutions presented at Cambridge Healthtech Institute’s Immunogenicity Summit in Washington, DC on November 11, 2013.

Pleximmune test to predict liver transplant rejection presented at the Liver meeting in Washington DC - November 3, 2013.

The Pleximmune test is the first blood test of its kind to predict whether acute cellular rejection will occur in children with liver or intestine transplantation. This information can help transplant physicians guide post-transplant care. During a six-year period, over two hundred and eighty blood samples from more than 200 children were tested in two groups. Samples from the first portion of the study period were termed the training set, and those obtained subsequently were termed the validation set.

American Transplant Congress, Seattle | 18–22 May 2013

The American Transplant Congress was held between May 18-22 in Seattle this year. The American Transplant Congress is the premier venue for scientific exchange between the various disciplines uniquely involved in solid organ transplantation.

ESOT Congress, Vienna | Sept 8-11

Results from Plexision’s pharma collaboration to be reported at the European Society for Organ Transplantation Congress, Vienna | September 8-11

Optimizing the effectiveness of a new immnosuppressant requires usage, which is informed by an understanding of individual rejection-risk and response to the drug. This knowledge can facilitate the design of novel regimens based on the new immunosuppressant, and the selection of patients suited for such regimens.

Plexision provides PK/PD services and dose-response modeling as the bases for drug target selection and development of companion diagnostics.

The European Society of Transplantation (ESOT) is a premier organization whose members include healthcare providers involved in the care of transplant patients in Europe and internationally.

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.