Biomarker Discovery
The pharmaceutical industry seeks cost-effective, robust efficacy and safety biomarkers that can be used for drug development. Biomarkers can be used for translation from preclinical to clinical studies. Biomarkers can be utilized in early development to decide whether to terminate substandard compounds or in later development to mitigate risk and maintain good drugs in development.
As part of its Critical Path Initiative, the FDA has identified the development of new biomarkers as one of the key opportunities to increase efficiency, predictability, and productivity in drug development. These new initiatives will accelerate the approvals of novel drugs by integrating biomarkers and pharmacogenomic tests into the clinical trial process. Subsequent utilization of companion diagnostics with therapies will better match therapy to individuals. The Agency and its counterparts in the major markets of the world are ready and willing to work with the increasing number of drug companies that are generating pharmacogenomics data. They have issued and refined guidance concerning pharmacogenomics data-submission, and encourage closer interactions between academia, industry, and regulatory agencies.
Unfortunately, the technologies utilized to assay many of these biomarkers can be cumbersome (metabolites), technically challenging (proteins), or expensive (imaging). Genes and their transcripts (nucleic acids) discerned by expression profiling have practical advantages. Nucleic acid measurement technologies such as microarrays and PCR are robust and adaptable to high throughput.
Learn more about Asuragen’s molecular profiling capabilities.
Description of Services
Additional Services Available
Catalog Numbers for Biomarker Discovery Services
Description of Services
- Feature (mRNAs, miRNAs) and model selection based on molecular profiling data Learn more
- Placement of putative biomarkers into biological context using pathway and functional group analysis Learn more
- Biomarker signature validation and performance evaluation
- Class Comparison: Identification of features (mRNAs, miRNAs, SNPs) correlating with a phenotype (such as clinical outcome)
- Class Prediction: Features correlating with a particular phenotype can be used together with classification algorithms to allow for prediction of response to therapy for future samples
- Class Discovery: Identification of features allowing for separation of samples into subtypes
Additional Services Available
Sample prep:
Cell lines – eukaryotic and prokaryoticBlood/biofluids
Frozen/RNAlater/RNAretain tissues
Fixed (FFPE) tissues
mRNA Analysis:
Affymetrix Gene Expression Profiling Services
Illumina Gene Expression Profiling Services
Applied Biosystems TaqMan Gene Expression Services
miRNA Analysis:
Ambion/Affymetrix DiscovArray miRNA Expression Profiling
Agilent Human miRNA Microarray Service
Applied Biosystems TaqMan miRNA Expression Services
DNA Analysis:
Applied Biosystems TaqMan Gene Expression or SNP Detection Services
Data Analysis:
Standard Service Premium
Full Service
Catalog Numbers for Biomarker Discovery Services
| CS0001 | Fee, Initial Consult or Design Plan |
| CS0010 | Data Analysis, per Custom SOW (applies to Biomarker Discovery) |