Biomarker validation services
Bioanalytical CRO

Biomarker discovery and validation services

We offer comprehensive biomarker discovery and validation services to support the development of personalized therapies, diagnostics, and precision medicine. Our expert team utilizes advanced technologies such as Next-Generation Sequencing (NGS), qPCR/dPCR, and Olink proteomics to identify and validate biomarkers critical for patient stratification, therapeutic response, disease prognosis, and safety monitoring.

Nucleic acid experts

Our technologies

We optimize and validate the entire workflow, from raw tissue specimens to the final data, ensuring the highest quality results are delivered.

NGS Services TATAA Biocenter
RNA-seq

We offer RNA sequencing solutions for total RNA and mRNA-seq analysis, as well as tag-based approaches like 3’-mRNA sequencing and small RNA-seq. These methods help identify biomarkers, reveal therapeutic targets, analyze drug response and resistance, elucidate mechanisms of action, assess immune response, and support various other applications.

DNA-seq

Through various DNA-seq applications, we simultaneously sequence the whole genome, exome, or targeted panels to reveal genetic variations, discover drug targets, understand disease mechanisms, stratify patients, and identify predictive or prognostic biomarkers, all at the DNA level.

PCR Analysis TATAA Biocenter
qPCR/dPCR for biomarker validation

We develop and validate biomarker quantification assays using dPCR/qPCR, offering high sensitivity, even for low-abundance targets, across a range of sample types in all phases of drug development. We use PCR-based assays to validate genetic, RNA, and miRNA biomarkers and gene expression quantification, mutation frequency detection, and copy number variation analysis.

Olink service provider TATAA Biocenter
Olink proteomics

Olink’s high-throughput, highly multiplex proteomics platform enables the analysis of over 5,400 proteins, or smaller targeted panels, from small sample volumes. This makes it ideal for discovering and validating protein biomarkers associated with disease pathways, therapeutic responses, or safety concerns.

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Automated workflows

Enhance precision and productivity with automation

Most pipetting steps can be fully automated with our advanced liquid handling platforms.

Automation standardizes processes, ensuring consistent and precise results across experiments. By automating repetitive tasks such as sample handling and assay preparation, we can manage a higher volume of samples, accelerate project timelines, and easily scale to accommodate studies ranging from preclinical to large clinical cohorts. Our automated systems are fully integrated with our LIMS, ensuring accurate sample tracking, data traceability, and regulatory compliance.

applications

Support at every phase for well-informed decisions

Our molecular analyses support every phase of drug development, from early discovery through biomarker validation to large clinical cohort studies for efficacy and safety. We ensure precise, actionable insights at each stage, enabling informed decisions throughout the development.

NGS Services TATAA Biocenter
Gene expression analysis
We offer comprehensive gene expression analysis services from early discovery through preclinical and clinical trials. We develop and validate assays for qPCR, dPCR, and Next-Generation Sequencing (NGS) to deliver precise, reliable, and regulatory-compliant gene expression data.
PK/PD​ TATAA Biocenter
Immunoprofiling and immune response monitoring

We provide advanced immunoprofiling and immune response monitoring services to support the development of immunotherapies, cell and gene therapies, vaccines, and other biologics. Utilizing TCR/BCR sequencing, qPCR/dPCR, NGS, and Olink proteomics, we offer in-depth insights into the immune system’s response.

Cell and gene bioanalysis

We develop and validate highly sensitive assays from complex samples and unique test items through to final data for biodistribution, shedding, PK/PD, and transgene expression. Depending on regulatory requirements, the analysis is performed as fit-for-purpose, GLP, or GCLP.

Transgene expression​ TATAA Biocenter
Small non-coding RNAs

We use Two-tailed PCR technology to analyze short targets such as miRNA and siRNA. This technology enables high-throughput, validated qPCR/dPCR analyses for bioanalysis or biomarker purposes of these short targets.

Olink service provider TATAA Biocenter
Quantitative proteomics

Olink’s proximity extension assays (PEA) enable multiplexed analysis of hundreds to thousands of proteins using just microliters of blood or plasma, ideal for immune applications, biomarker discovery, or biomarker validation.

Genomic profiling and mutation detection

Our genomic profiling and mutation detection services identify key mutations for personalized therapies. We perform whole genome sequencing (WGS), exome sequencing, and targeted gene panels to deliver insights into SNPs, indels, CNVs, and structural variants.

Extraction

Accurate quantification begins with precise extraction

Comprehensive extraction across all sample types and test items

We have extensive experience extracting nucleic acids from various biological samples, including tissues, biofluids, swabs, excreta, secreta, fresh frozen, or FFPE-fixed.

Our expertise covers the extraction of different types of nucleic acids, including DNA, cfDNA, short RNAs (miRNA, siRNA, and more), messenger RNA, and ASOs with diverse modifications and chemical properties.

We consistently include spike-ins to ensure efficient extraction, optimal quality for downstream applications, and the removal of inhibitory agents. Our goal is the accurate quantification of the target molecule, where precise, high-quality extraction is essential for achieving both accuracy and precision.

About us

The power of our approach

Committed to quality, innovation, and fostering strong client relationships, we serve as your trusted partner to accelerate drug development. As a contract research organization, our mission is to push the boundaries of science and technology to generate accurate and reproducible data that shortens time-to-market.

Regulated laboratory environment

We are GLP accredited for qPCR, dPCR, and molecular biology, GCLP compliant, and ISO/IEC 17025 accredited. Our facility features a strict sample management process, a fully integrated LIMS system, backup for all vital systems, temperature and humidity control, and robust IT security.

Purpose-built PCR laboratory

Our purpose-built laboratory in Gothenburg, Sweden, is specifically designed for PCR. It has controlled air pressure, temporal separation, and biosafety cabinets to minimize contamination risk. This setup enables us to achieve the highest sensitivity and robustness required for validated assays. The lab is equipped with market-leading PCR and NGS instruments and advanced liquid handling systems.

Pioneers in assay development and validation

We are a team of 45 employees, with scientists at the forefront of assay development, optimization, and validation. Our team has co-authored key publications in the field, including Recommendations for Method Development and Validation of qPCR and dPCR Assays in Support of Cell and Gene Therapy Drug Development (AAPS J. 2024) and The MIQE Guidelines for qPCR and dPCR.

Flexible, client-centered solutions

We work closely with our clients to find tailored solutions, offering flexibility in sample types, test items, sample volume, and scalability. We prioritize transparency and proactive communication throughout each project, ensuring our clients are continuously updated on the progress.

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Let's explore how we can support your drug development program

PK/PD​ bioanalysis

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