Use of MSD-ECL in Support of Multiplex Biomarker Study
Case Study

Use of MSD-ECL in Support of Multiplex Biomarker Study

Challenge

A top-five pharmaceutical company needed several angiogenesis biomarkers analyzed to support multiple Phase I clinical oncology studies.

The analysis required multiple quantified biomarkers, and the provided sample volume was small. The project also required a high level of specificity, meaning BioAgilytix needed to differentiate between multiple biomarkers. In addition, the study size required testing of a large number of samples.

Study Background

  • Type of Study

    Angiogenesis biomarker analysis

  • Regulatory Parameters

    Biomarkers must be quantified

  • Objective

    Identify biomarkers to be used in support of Phase I clinical oncology studies

Use of MSD-ECL in Support of Multiplex Biomarker Study

Solution

Working together with the sponsor, BioAgilytix identified seven relevant biomarkers to follow in support of the studies. Considering the study requirements and biomarkers of interest, the MSD-ECL platform was determined to be the best-fit technology. Scientists then qualified and validated a 7-plex assay that required only 100 ul of sample. The resulting assay allowed the BioAgilytix team to run several thousand samples a day, providing the quality and throughput the client required.

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.
  • Experience conducting studies with small sample volumes.

Combining scientific expertise and innovative thinking, BioAgilytix found the solution that would meet all the study’s needs in the most effective way possible.

Outcome

The seven newly quantified biomarkers are now used to support over thirty Phase I, II, and III projects. The method is proving out and providing important data in the project’s clinical development phase.

These projects span disease states to include studies for bladder, colon, breast, prostate, and lung cancers.