Biomarker discovery and validation services
Proteomic, transcriptomic, and genomic exploratory biomarker analysis services for clinical and preclinical drug development.
Biomarker discovery techniques
RNA biomarker discovery
Comprehensive transcriptome profiling to compare expressed RNA (total RNA, mRNA, or miRNA) between groups, such as treated vs. non-treated or responders vs. non-responders, enabling patient stratification and biomarker discovery using next-generation sequencing technologies. As a biomarker discovery laboratory we optimize the entire workflow, from sample (tissue or biofluid) to bioinformatics.
Protein biomarker discovery
Pre-defined affinity-based proteomic biomarker panels targeting specific pathways and disease areas or full discovery panels enable blood and plasma proteomics biomarker discovery using just microliters of sample. Our optimized, automated workflows ensure high efficiency, offering deeper circulating biomarker discovery than methods like LC-MS/MS.
Genomic biomarker discovery
Genomic biomarker discovery involves identifying genetic variations, such as SNPs, that serve as biomarkers for prognosis, treatment response, or pharmacogenomic applications. These biomarkers are detected using comprehensive next-generation sequencing technologies, including whole-genome and whole-exome sequencing. We provide optimized and automated workflows, supporting small-scale studies and large high-throughput analyses.
Biomarker qualification and validation
Once a candidate biomarker is identified, qualification and validation requires precise, reproducible, and quantitative methods in relevant sample cohorts. We design, optimize, and validate high-precision methods, such as qPCR and dPCR, for RNA and DNA biomarker validation, supporting small-scale studies and high-throughput clinical trial sample analysis.
GLP and GCLP compliant laboratory
We are accredited for Good Laboratory Practice (GLP) by the Swedish Board for Accreditation and Conformity Assessment (SWEDAC) for qPCR, dPCR, and molecular biology. In addition, we are Good Clinical Laboratory Practice (GCLP) compliant to ensure the safe and reliable analysis of clinical samples.
Biomarker discovery at TATAA
Samples
- Samples
- Tissues
- Blood
- Liquid biopsies
- Fresh frozen
- FFPE
- EDTA
- PAXgene tubes
Analytes
- Total RNA
- mRNA
- miRNA
- SNPs
- CNVs
- Inflammatory proteins
- Circulating proteins
A primary biomarker directly measures the effect of a treatment, such as gene silencing in siRNA therapeutics. It reflects the drug’s mechanism of action, as siRNA-based therapies work by degrading specific mRNA transcripts. A secondary endpoint provides additional supportive evidence of the drug’s efficacy. For example, if the primary biomarker in siRNA therapy is the reduction of LDL cholesterol, a secondary endpoint could be the reduction of a cardiovascular risk marker.
When protein levels cannot be reliably measured, such as in transgene expression, where the transgene protein is often present at very low levels, mRNA levels can serve as a surrogate marker. This is possible because qPCR and dPCR are highly sensitive and selective, allowing for precise detection of transgene mRNA while distinguishing it from endogenous mRNA.
A prognostic biomarker predicts disease progression, survival, or risk reduction independently of any specific therapy. In contrast, a predictive biomarker identifies which patients will likely benefit from a particular treatment.
A stratification biomarker is similar to a predictive biomarker in classifying patients into subgroups. However, the key difference is that a stratification biomarker does not necessarily indicate treatment response, it only defines a specific patient subgroup based on biological or clinical characteristics.
Stratification biomarkers are primarily used in clinical trials to design subgroup analyses, ensuring that patients with similar characteristics are evaluated together. On the other hand, predictive biomarkers are essential for precision medicine, helping guide treatment selection for individual patients.
Resources
Overview of bioanalysis in advanced therapies
- Assay design and validation
- Regulatory guidelines (EMA and FDA)
- Challenges and best practices
Genomic biomarker analysis (DNA, RNA, miRNA, ctDNA etc,)
- Technology overview
- Analytical validation
- Regulatory overview
Capability PDF
Download our latest brochure for a summary of our molecular CRO services and capabilities.