Novoleukin Test System

What is involved in Novoleukin
testing at the trial site and central lab?

1. Draw Blood

Simple blood draw process.

2. Antigen Tubes & Incubate

Transfer into custom antigen tubes and incubate.

3. Separate Plasma

Separate and store plasma.

4. Cytokine Measurement

Central lab cytokine measurement.

5. Results

Ultrasensitive T cell monitoring results.

Our Novoleukin T-cell testing system detects T cells when others don’t. 




  • Low limit of detection for rare antigen-specific T cells.

  • Ease of use - low volume of blood required allows repeat testing and better patient experience.

  • Fit for Purpose assay with optimised incubation conditions to maximise cytokine secretion.


Why choose the Novoleukin Test System?

Precision

Low limit of detection for rare antigen-specific T cells translates to clinical sensitivity and specificity.


The company’s key, proprietary intellectual property is the Novoleukin test system, a “whole blood antigen-stimulated cytokine release assay” which is substantially more sensitive than conventional fresh PBMC-based ELISpot assay (e.g. for detection of gluten-reactive CD4+ T cells in celiac disease).


Novoviah provides test kits designed for your therapeutic, allowing immune monitoring at community clinical sites during trials. 


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Simplicity

Only 4 ml blood sample is required for each test condition; for example, in celiac disease studies this can ease the burden on patients and sites by reducing the need for invasive or unpleasant procedures such as endoscopic biopsies or “gluten food challenge”.


The protocol for blood collection and processing is simple and reproducible, to enable easy rollout across multiple sites.

Customised

The Novoleukin Test System comprises three elements: 


  1. Novoleukin test kit and protocol for collecting and processing fresh blood at the trial site.
  2. Novoleukin customised antigenic-peptide mixtures and matched controls for specific stimulation of cytokine release from cognate T cells in blood.
  3. Central Lab performing ultrasensitive cytokine assay.

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