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Biomarkers in Oncology


We are pursuing the era of personalized medicine through biomarkers.

The Importance of Biomarkers

Biomarkers are an increasingly important component of our drug development activities, and they are used in multiple ways. We see enormous potential in transforming predictive biomarkers into companion diagnostic tests that can then be used in the clinic to help guide targeted, individualized use of our therapies. As a result, a growing number of our pipeline products have a companion diagnostic in development. We call this the “diagnostic-therapeutic convergence,” and it is essential if we are to realize the ultimate goal of personalized medicine – that is, the ability to deliver the right treatment at the right time and the right dose to the right patient.

Our molecular pathology core laboratory in Janssen Research & Development supports Oncology Biomarkers and Discovery to validate drug targets and to discover markers that predict which patients will likely respond to our exploratory compounds. We have a fully equipped histochemistry laboratory with digital histology capabilities and offer the following core technologies and capabilities:

  • Circulating Tumor Cells (CTCs)
  • Immunophenotyping
  • Molecular Pathology (IHC, FISH)
  • Digital Pathology
  • Genomics (transcriptional profiling, miRNA analysis, qPCR, RT-PCR, NGS, exome Seq, WGS)
  • Pathway Analysis
  • Protein Assay Development
  • Bioinformatics
  • Cell Based Assays
Some Examples of Our Work in Biomarkers

Androgen Receptor (AR)

The androgen receptor (AR) plays an important role in the normal development and maintenance of the prostate. However, multiple changes occur in the AR-axis across disease stages, including the generation of AR splice variants, which allow continual androgen signaling to occur. Several changes have been identified, including AR splice variants. Janssen biomarker scientists have developed tests to detect the presence of these AR abnormalities. Efforts are also ongoing to understand the “AR-axis” in CTCs. AR-axis tests are designed to detect multiple biomarker changes at the same time.

Fibroblast Growth Factor Receptor (FGFR)

FGFRs are tyrosine kinase receptors involved in signal transduction. Deregulation of the pathway controlled by these receptors normally leads to cancer. In collaboration with Astex, Janssen has identified a small molecule inhibitor that has activity against the four receptors in this family. We have identified biomarkers that enable our clinical team to design studies that select for patients who we believe will be more responsive to the drug.

Bruton’s Tyrosine Kinase (BTK)

Studies suggest that normal B-cells, and potentially their malignant counterparts, require B-cell receptor signaling through BTK for maturation and survival. Our current biomarker activities are focused on characterizing molecular and genetic mechanisms of tumor cells that lead to drug resistance, and identification of biomarkers associated with B-cell receptor pathway addiction (i.e., drug sensitivity).



Human lung bronchioalveolar carcinoma cell