Biomarkers

Identify, characterize, exploit, as a translational tool, companion or diagnostic test

Biomarker discovery

Biomarker validation

Biomarker clinical relevance confirmation

Biomarkers

Biomarkers

In the field of biomarkers, our added value lays on:

  • Integration of biomarker expertise from discovery to development phases
  • Collaboration with clinicians and key-opinion leaders in relevant therapeutic areas
  • Extensive portfolio of biomarker assays, validated for research and development
  • On purpose technological development of assays and data analysis

Biomarkers play an important role in the development of personalized medicine. Single biomarker or combination of markers, defined as signatures, can be host- or pathogen-related.

They can be used in disease diagnosis, as prognostic indicators, for developing individualized therapeutics, for predicting and treating adverse drug reactions or for pharmacodynamic and dose-response studies.

To meet your biomarker need as research or translational tool, or for companion/diagnostic tests, we propose a multistep and iterative approach that combines well-controlled biomarker process with fit-to-purpose analytical technology that helps building a strong biomarker testing strategy across all phases of development mitigating risks at key stages of your program.

Discovery and validation of biomarkers request a strong multidisciplinary synergy between our scientists, clinician partners, and our data analysts to ensure scientific excellence and a benefit to your study. Furthermore, the importance of well-designed study and a shared understanding – at the onset of the project – of the expected target biomarker profile that fits with the unmet need must not be underestimated.
A three-stage process is setup according to the targeted (hypothesis-based) or non-targeted (discovery-based) approach defined with you at the onset of the program.

Biomarker discovery
Aim: identify candidate biomarkers using
OMICS technology

Biomarker validation
& analytical technology development
Aim: confirm candidate biomarkers in an independent study with an adapted analytical device

Biomarker clinical relevance confirmation
Aim: demonstrate the clinical relevance of biomarkers in larger cohort with the most advanced (or IVD-graded) bioanalytical device

1

Biomarker discovery

The outcome of this phase is to identify candidate biomarkers whose expression is significantly correlated to a drug mode of action, to a physiopathological change in a disease, to the presence of a pathogen, during a therapy or in treatment safety or efficacy study.

Our experts will help you to design your study in a customized way and to define the most appropriate analytical technology for this discovery phase by taking into account several factors like i) the nature of the biomarker (molecular, protein, metabolites, lipids,..), ii) the type and the origin of specimens (human vs animal; tissue, organs, biofluids) that will impact sample preparation method, iii) the target application (drug development, companion or diagnostics) and iv) the final users (laboratory vs point-of-care tests).

We provide a large portfolio of advanced “OMICS” technologies with reliable protocols from the sample preparation initial step until complex & multi-source dataset bioinformatics/biostatistics analysis in the field of genomics, transcriptomics, proteomics and metabolomics. Systems biology that harness complex, multi-gene systems by computationally integrating gene-level data with molecular pathways and networks to extract new biological insight may also improve current strategies of biomarker discovery.

Learn more about our OMICSXdata technologies.

Biomarker discovery
2

Biomarker validation & analytical technology development

Biomarkers identified with targeted (hypothesis-based) or non-targeted (discovery-based) approach require rigorous validation.

We will help you successfully pass this challenging phase that is pivotal to move biomarker towards clinical implementation; this step is based primarily on confirming the candidate markers in an independent study using human specimens or in animal model with support of technically validated bioanalytical platforms suited to the study. According to the nature and the number of markers studied, single/multiplex qPCR, flow cytometry or multiplexed immunoassay platforms can be used. Biostatistical methods are applied to reduce the set of genes of interest and to define the final signature with the highest diagnostic performances.

Microsystem-based devices can be a technology of choice to validate presence and relevance of a biomarker. As an example, we apply droplet-based single-cell analysis of cellular phenotype that provide sensitivity and resolution for biomarker validation unattainable by current bulk methods. Single-cell resolution can reveal treatment resistance mechanisms or abnormal immune response to better stratify patients in clinical trials.

Biomarker validation & analytical technology development
3

Biomarker clinical relevance confirmation

From a therapeutic perspective, we help you demonstrate the benefit of surrogate endpoint biomarkers in pre-clinical or early clinical phase studies to minimize the number of patients, as well as the time and resources, required for pivotal studies.

From a diagnostic standpoint, we will support you to demonstrate the clinical relevance and usefulness of the markers either as companion diagnostics or in diagnosis. Validated biomarkers will be measured in a larger cohort with the most advanced (or IVD-graded) bioanalytical device that can be a molecular platform (e.g. NGS, simplex or multiplex qPCR assays), an automated immunoassay platform that will be used in laboratory or a rapid diagnostic test at the patient bedside.

To reach this goal, we partner with a clinical network (hospitals, clinics) for access to well-characterized human biospecimens associated to high quality clinical and microbiology data in a retrospective or a prospective way. Support of BIOASTER in conducting observational and longitudinal clinical studies involves CRF, ICF, protocol writing and regulatory submissions in Good Clinical Practice under the ISO9001 Standard Certification.

Read more about Clinical Operations technology.

2

Biomarker validation & analytical technology development

Biomarkers identified with targeted (hypothesis-based) or non-targeted (discovery-based) approach require rigorous validation.

We will help you successfully pass this challenging phase that is pivotal to move biomarker towards clinical implementation; this step is based primarily on confirming the candidate markers in an independent study using human specimens or in animal model with support of technically validated bioanalytical platforms suited to the study. According to the nature and the number of markers studied, single/multiplex qPCR, flow cytometry or multiplexed immunoassay platforms can be used. Biostatistical methods are applied to reduce the set of genes of interest and to define the final signature with the highest diagnostic performances.

Microsystem-based devices can be a technology of choice to validate presence and relevance of a biomarker. As an example, we apply droplet-based single-cell analysis of cellular phenotype that provide sensitivity and resolution for biomarker validation unattainable by current bulk methods. Single-cell resolution can reveal treatment resistance mechanisms or abnormal immune response to better stratify patients in clinical trials.

Biomarker validation & analytical technology development

Usefulness of biomarkers in diagnostics, companion diagnostics and for support of vaccine & drug development/translational research:

Diagnostic Companion Diagnostics Support of Vaccine/ Drug Development
& Translational Research
Biomarker utility Diagnosis, prognosis, treatment monitoring of a disease.
Highly recommended for safe prescription and good medical practice.
Selection of the right patients.
Associated to a targeted therapy (Personalized Medicine). Predictive to treatment outcome.
Vaccine/drug mode of action.
Characterization of physiopathology.
Translational tools.
Safety/efficacy assessment.
Technology required for development OMICS-based or biomarker-specific detection platforms. Specific detection platforms. OMICS-based or specific detection platforms.
Type of technology for final biomarker analysis Point of care, laboratory testing. Point of care, laboratory testing. Laboratory testing.
Regulatory basis IVDR registration. Drug-diagnostics co-registration. Not applicable.
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