Inflammatory Biomarker Discovery on Luminex-BioPlex
Case Study

Inflammatory Biomarker Discovery on Luminex-BioPlex

Challenge

A client supplied a set of pre- and post-dosed samples sourced from a clinical trial they were conducting, and tasked BioAgilytix with evaluating the samples for possible biomarkers indicative of an inflammatory response. Based on literature searches and the sponsor’s knowledge on the potential pathways for inflammatory response, twelve possible biomarkers were identified as possible initial leads. The sponsor needed to identify the most relevant biomarker for their study from this existing list.

Study Background

  • Type of Study

    Biomarker sample evaluation

  • Regulatory Parameters

    Discovery phase

  • Objective

    Identify possible biomarkers indicative of an inflammatory response

Inflammatory Biomarker Discovery on Luminex-BioPlex

Solution

Due to the multiplexing need and variability in the endogenous concentrations of these biomarkers, BioAgilytix scientists chose the Luminex Bio-Plex as the preferred platform. However, due to severe antibody cross reactivity issues, two separate multiplex panels (7-plex and 5-plex) needed to be developed. Finally, scientists analyzed each of the samples (pre- versus post-dose) and used SAS-JMP statistical software to look for significant changes in the biomarker levels.

The following areas of expertise were vital to BioAgilytix’s overall solution:

  • Considerable experience working with biomarkers for a variety of disease states.
  • Expertise in choosing the best-fit technology in studies with specific requirements.
  • Years of experience operating the Luminex Bio-Plex to produce accurate results.

Combining scientific platform expertise with attention to the sponsors’ needs and input, BioAgilytix collaboratively identifies a solution that would effectively identify the most relevant biomarker from the sponsor’s existing list.

Outcome

One biomarker was discovered as the most relevant lead, thus allowing the development of a fully validated quantitative assay on the MSD-ECL platform for the next phase of the study.