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Biomarker Discovery

Biomarker discovery and validation in clinical trials are essential for tailoring treatments to individual patients and improving overall trial outcomes. These processes help identify biomarkers that predict disease progression, treatment response, and adverse effects, guiding therapeutic strategies and enhancing trial efficiency. Validated biomarkers ensure reliable and reproducible results, supporting their integration into clinical practice for more precise and effective patient management during trials. This approach accelerates drug development and fosters personalized healthcare approaches within clinical trial settings.

Our Expertise

With extensive expertise in genomic and protein analysis for clinical trials, we employ a wide range of cutting-edge technologies for biomarker discovery and validation. This includes Sanger sequencing, qPCR, NGS, ddPCR, ELISA, MSD assays, automated western blotting, and flow cytometry. These capabilities deliver crucial molecular insights, supporting the development of innovative therapies and personalized healthcare solutions. We help our clients for:

  • Biomarker Discovery: uncover new biomarkers that can be used for disease detection, diagnosis, prognosis, and treatment monitoring, using state-of-the-art analytical technologies.
  • Biomarker Assay Validation: verify that a biomarker assay (test) reliably and accurately measures the biomarker of interest. This includes assessing the assay’s sensitivity, specificity, reproducibility, and accuracy.
  • Biomarker Clinical Validation: establish that the biomarker has practical value in a clinical context, such as predicting disease risk, diagnosing a condition, predicting response to treatment, or monitoring disease progression.

Types of Biomarkers

Types

Description

Risk Stratification

Risk stratification biomarkers are essential for preventive medicine.

Disease Screening and Detection

Screening biomarkers are crucial for identifying diseases when they are most treatable.

Diagnostic Biomarkers

Diagnostic biomarkers provide definitive evidence of a disease, aiding in accurate diagnosis.

Prognostic

Prognostic biomarkers help determine disease progression and patient prognosis, regardless of treatment

Predictive

Predictive biomarkers are vital for personalized medicine, guiding treatment choices based on a patient’s likelihood of responding to a particular therapy.

Technology We Offer

Services

Purpose

Technology

Gene Expression

Identifies gene expression biomarkers for predicting treatment outcomes, monitoring treatment efficacy, and understanding disease pathways.

  • RNA sequencing (RNA-seq)
  • Real-time PCR(RT-qPCR)
  • Digital droplet PCR (ddPCR)

Genotyping

Used to stratify patients based on genetic profiles and predict their responses to therapies.

  • Amplicon Sanger sequencing
  • Amplicon NGS
  • TaqMan assays
  • End-point PCR

Protein Analysis

Identifies protein biomarkers for disease diagnosis, prognosis, and monitoring treatment efficacy.

  • Enzyme-linked immunosorbent assay (ELISA)
  • Meso Scale Discovery (MSD)
  • Westen blotting (Jess)
  • Flow Cytometry
  • LC/MS/MS (coming soon)

Metabolomics

Provides insights into metabolic pathways and identifies metabolic biomarkers related to disease and treatment response.

  • LC/MS/MS (coming soon)

Epigenetic Analysis

Identifies epigenetic biomarkers that can influence gene expression and disease outcomes.

  • Bisulfite sequencing

  • Chromatin immunoprecipitation (ChIP)
  • Methylation-specific PCR

Immunoassays

Identifies immune-related biomarkers for diseases, especially in immunotherapy and infectious diseases.

  • ELISA
  • MSD
  • Flow Cytometry

Cytogenetics

Identifies chromosomal biomarkers related to cancer and genetic disorders.

  • Fluorescence in situ hybridization (FISH) (coming soon)
  • Karyotyping (coming soon)

Phenotyping

Used for immunophenotyping to identify and classify different cell types, particularly in immunology and oncology, and to assess cellular responses to treatments.

  • Flow Cytometry

Microbiome Analysis

Identifies microbiome-related biomarkers that can impact health and treatment outcomes.

  • 16S rRNA sequencing
  • Metagenomic sequencing

Single Cell Sequencing

Offer unparalleled insights into the genetic and molecular heterogeneity of biological samples at the single-cell level.

  • Mission Bio Tapestri Platform

Have Questions?

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