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.
Asuragen participated in the
MAQC-II FDA initiative to set standards for biomarker discovery and validation.
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
gene expression and
miRNA profiling services.
Description of Services
- Feature (mRNAs,
miRNAs) and model
selection based on molecular profiling data
- 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 prokaryotic
Blood/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
miRNA Microarray Service
Applied
Biosystems TaqMan miRNA Expression Services
DNA Analysis:
Agilent aCGH
Affymetrix SNP 6.0 - coming soon
Data Analysis:
Standard
Service Premium
Full
Service
Catalog Numbers for Biomarker Discovery Services
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CS0001
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Fee, Initial Consult or Design Plan
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CS0010
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Data Analysis, per Custom SOW (applies to Biomarker Discovery)
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