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Genomic Biomarker Services
Discovery, Detection and Screening
Successful genomic biomarker programs rely on the ability to accelerate basic and translational research programs to speed the development of safe and effective pharmacological agents. These programs are also the key to individualizing medical treatment and bring the era of personalized medicine to reality. Beckman Coulter Genomics provides genomic biomarker services to support discovery, screening and detection of biomarkers.
Genomic biomarker discovery and development is supported with the following applications:
- Nucleic acid extraction
- Sequencing
- Variation discovery and genotyping analysis
- Gene expression profiling
Services are performed under stringent regulatory guidelines, including Good Clinical Practices (GCP), Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP).
Whole Genome/Transcriptome Analysis
Comparison of variations across the entire genome can be used to identify genomic regions of interest and evaluate candidate biomarkers. Analyses include next generation sequencing for DNA and RNA based applications.
Diagnostic Kit and Device Validation
Based on individual client's needs, custom projects can be designed to support validation of assays and to support 510(k) applications for diagnostic kits and devices. Substantial equivalence testing is proven by starting with nucleic acid extractions and template amplification, followed by a "gold standard" reference method such as GLP/cGMP bidirectional sequencing to identify variations within the gene of interest.
Study Design, Bioinformatics and Data Analysis
Beckman Coulter Genomics provides guidance for the development of both prognostic and predictive biomarkers from early phase development through clinical validation of stratification markers. A team of professionals can assist with:
- Study design
- Marker selection
- Power and sample size evaluation
- Normalization
- Class discovery
- Class comparison
- Class prediction
- Data quality assessment
By gaining a better understanding of the significance of the data being generated clients are able to identify responders and non-responders. This enables customers to transform data into biologically relevant information.
