Biomarker Assay Development


HistoGeneX provides a complete portfolio of biomarker assay development and validation services that can be used from preclinical development through proof of concept. We also assure a seamless transition of procedures and technology for biomarker testing in clinical trials.

We have developed over 1000 biomarker assays for exploratory and clinical trial uses. We merge powerful data collaboration tools with automated solutions to create a real time interactive environment with our sponsors. These include a sophisticated combination of documents, images and secure data exchange technologies. 

Biomarker assays bridge histology and/or molecular biology techniques to the experimental design to provide an invaluable dimension to the pharmaceutical research. Well-developed biomarker assays offer insight at the cellular level, an essential aspect for studies such as model development, proof-of-concept, pharmacokinetics, pharmacodynamics, safety and efficacy and validation, both in vivo and in vitro. 

All assay development services are performed in compliance with GCLP regulations and led by a highly trained team of scientists (PhD or MSc level). Expertise is covered in a range of therapeutic areas including oncology, cardiovascular disease, diabetes, neurological disorders, pain, wound healing and others. 

HistoGeneX provides scientific consultancy and customized project management through your entire study.

What assay development services does HistoGeneX offer?

HistoGeneX provides customized fit-for-purpose assay development projects. We will tailor our work to accommodate the intended use requirements of your biomarker assay such as:

  • Technical: Reagents, Methodology, Image Analysis
  • Specimen: Fixation, Viability, Collection method
  • Platform: Automated platform choice
  • Regulatory: Exploratory, Registration-class or Companion Diagnostic

Depending on the purpose, HistoGeneX will assign team members with the necessary experience.

Does HistoGeneX offer de novo assay development?

Yes, HistoGeneX works with its partners to develop primary antibodies for IHC, or FISH and mRNA probes. HistoGeneX will be responsible for managing the development of these de novo reagents.

Can I transfer my assay to HistoGeneX for further validation or clinical deployment?

Absolutely. HistoGeneX scientific experts and project management team and fully acquainted with transfer protocols. Our usual process includes:

  • Teleconference with HistoGeneX assay team including board-certified pathologist
  • Discussion of target of interest and sample requirements
  • Approval by Sponsor of work scope
  • Budget & milestones definition


What methodologies are available at HistoGeneX for assay development?

A full complement of tissue-based platforms are available at HistoGeneX for your assay development needs:


What deliverable(s) will I receive for an assay development project?

HistoGeneX will provide a customized validation report for each project. For larger and complex projects, we will provide a summary presentation, if desired.

How does Histogenex manage assay development projects?

We will assign a Scientific Expert and a Project Manager. We will schedule interim project teleconference updates. For larger projects, we will schedule an in-person presentation. Our teams will provide regular updates. We operate collaboratively with full transparency to optimize a successful assay development project outcome.