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End-to-End Biomarker Development: From Discovery to Clinical Validation

Biomarkers
Validation

+ 0

Biomarker in
Clinical trial phase

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Biomarker testing is a cornerstone of modern drug development. It enables researchers to assess disease progression and treatment response. We are an innovative Contract Research Organization with 11 platforms and the expertise in providing multiple accurate and reproducible biomarker analysis to biotechnology companies, pharmaceuticals, and academic researchers.

Our Core Biomarker Expertise:

  • Initial Biomarker Screening & Identification: We leverage cutting-edge platforms to explore and identify promising biomarker candidates, guiding early target validation and mechanistic understanding.
  • ELISA & Multiplex Assay Development: Specializing in custom ELISA development for R&D, we also excel in advanced multiplex analysis, enabling simultaneous quantification of multiple analytes for comprehensive biological profiling.
  • Automated Western Blot Technology: Our expertise extends to automated Western blot for precise protein quantification and characterization, ensuring high sensitivity and throughput for critical protein analysis.
  • Bioassays for Biomarker Analysis: We utilize a range of bioassays to assess biological activity and functional responses, critical for understanding drug mechanism of action (MOA) and therapeutic efficacy.
  • High-Sensitivity Detection: Our platforms and methodologies are optimized for detecting low-abundance biomarkers, crucial for early disease detection and subtle treatment response monitoring.
  • Pharmacokinetics (PK) & Pharmacodynamics (PD) Biomarker Analysis: We develop and validate high-throughput PK/PD assays to elucidate drug exposure-response relationships and ensure MOA alignment throughout preclinical and clinical development.
  • Cellular & Molecular Characterization: Beyond soluble biomarkers, we offer services for in-depth cellular and molecular characterization, providing a holistic view of drug effects.
  • Gene Expression Analysis: From exploratory gene profiling to targeted gene expression quantification, we provide robust data to understand transcriptional changes relevant to disease and drug action.
  • Analytical Chemistry & Purity Testing: Ensuring the integrity of your drug candidates and reagents, our analytical chemistry services provide crucial purity and characterization data.
  • Qualifications & Validations (GLP-Compliant): We adhere to rigorous scientific standards, including the development of robust SOPs and performing comprehensive qualifications and validations, supporting GLP-compliant studies essential for IND-enabling packages.
SPEAK WITH OUR EXPERTS

You choose we deliver

1. Biomarker Discovery & Early Screening

Identifying the Right Biomarker

The journey begins with exploratory research, where we help you identify potential biomarkers linked to disease mechanisms or therapeutic response. Using high-throughput screening and multi-omics approaches, we analyze:

  • Protein biomarkers (cytokines, enzymes, antibodies)
  • Genetic markers (SNPs, gene expression, fusion genes)
  • Metabolites & small molecules

Our Technologies:

  • ELISA development & optimization – Custom assays for novel biomarkers.
  • Multiplex platforms (Luminex ®, ELLA, MSD) – Simultaneously screen dozens of analytes.
  • Gene expression analysis (qRT-PCR, RNA-Seq) – Identify transcriptional signatures.

Outcome: A shortlist of high-potential biomarkers 

2. Analytical Validation: Ensuring Precision & Reproducibility

"Does the Biomarker Assay Work Reliably?"

Before clinical use, biomarkers must undergo rigorous analytical validation to ensure accuracy, sensitivity, and specificity. Our team performs:

  • Assay development & optimization – Tailored to your biomarker’s unique properties.
  • High-sensitivity detection – Measuring low-abundance biomarkers in complex matrices (serum, CSF, tissue lysates).
  • Stability & robustness testing – Evaluating freeze-thaw cycles, sample storage conditions.
  • Cross-validation – Confirming results with orthogonal methods (e.g., ELLA vs. ELISA).

Key Deliverables:

  • Fully validated assays (fit-for-purpose or GLP-compliant).
  • Standard Operating Procedures (SOPs) for seamless tech transfer.

3. Clinical Validation: Linking Biomarkers to Patient Outcomes

"Does the Biomarker Predict Disease or Treatment Response?"

A biomarker is only meaningful if it correlates with clinical endpoints. We support retrospective & prospective studies to establish:

  • Diagnostic accuracy (sensitivity, specificity, ROC curves).
  • Prognostic value (biomarker levels vs. disease progression).
  • Predictive power (response to therapy, e.g., PD-1 inhibitors).

Our Approach:

  • Pharmacokinetics (PK) & Pharmacodynamics (PD) – Tracking drug exposure vs. biomarker modulation.
  • Cellular & molecular characterization – Flow cytometry, IHC, single-cell RNA-Seq.
  • Multiplex biomarker panels – Uncovering immune, metabolic, or genetic signatures.

Outcome: Data to support IND submissions or clinical trial stratification.

4. Companion Diagnostic (CDx) Development

"Can This Biomarker Guide Treatment Decisions?"

For biomarkers destined to become CDx assays, we ensure they meet FDA/EMA standards for:

  • Reproducibility – Inter-lab concordance testing.
  • Clinical utility – Prospective trials validating biomarker-drug pairing.
  • Regulatory compliance – Assay validation under CLIA/GLP guidelines.

Our Expertise:

  • Anti-drug antibody (ADA) & neutralizing antibody (NAb) assays – For biologic therapies.
  • Liquid biopsy development – ctDNA, exosome-based biomarkers.
  • IVD partnership support – Bridging research-use-only (RUO) to CDx.

Use case - pTau217 Ella Results

Sample Analysis Overview

Group Average pTau217 (pg/ml) Std. Dev. Median
Alzheimer's Disease 1.2 0.8 1.1
Healthy 0.3 0.2 0.3

The analysis shows clear differentiation between disease and healthy samples. Alzheimer’s patients show significantly higher pTau217 concentrations.

1.2

0.3

4X

Disease Average

Mean pTau217 concentration (pg/ml)

Healthy Average

Mean pTau217 concentration (pg/ml)

Difference

Higher levels in disease samples

Clinical Implications

Biomarker Detection

pTau217 successfully measured in plasma samples

Disease Differentiation

Clear separation between disease and healthy samples

Clinical Application

Potential for Alzheimer's Disease detection