Biomarker-IVD Validation

Expert Skills in Statistical Validation of Biomarker and Diagnostics/IVD

Gain Time and Efficiency Through a Faster Biomarker and Diagnostics/IVD Validation

ANALYTICAL AND CLINICAL VALIDATION OF BIOMARKERS-IVDs

IDDI has advanced knowledge and extensive real-world experience delivering innovative analytical strategies to pharmaceutical and biotech companies.

ANALYTICAL VALIDATION

Different aspects of assay performance:

  • Precision, limit of detection and linearity
  • Sensitivity, specificity, and predictive values
  • According to ISO standards and CLSI guidelines
  • For different assay platforms: single/multiplex, microarrays, mass-spectrometry, ELISA, RT-PCR, etc.

CLINICAL VALIDATION AND UTILITY

Efficiency and reliability for clinical use

  • Validation of biomarkers coupled with the therapeutic development.
  • Validation of biomarkers in the absence of a gold standard
  • Increased efficiency and reduced costs by using a unique Bayesian methodology that takes development data into account.

IDDI has developed a Bayesian approach to accelerate the development and validation of Biomarkers. 
This methodology, which provides a more intelligent, faster and cheaper biomarker validation and development process, has been tested for Alzheimer’s Disease and is also suitable for other therapeutic areas.

Leverage IDDI statistical methods to identify and validate your single biomarkers, biomarker profiles and IVDs.

59
Publications
75
Trials in oncology, CNS (AD) and others

The development and qualification of biomarkers are keys to the future of drug development and personalized medicine.

Precision medicine relies on validated biomarkers that allow classification of patients by their probable disease risk, prognosis, or response to treatment. 

Our statisticians have developed methods and published extensively on surrogate endpoints and biomarker-based endpoints to expedite drug development in precision medicine, notably in cancer research.


BIOMARKER APPLICATIONS

IDDI has experience in the challenging statistical issues that characterize the identification and validation of biomarkers of diagnostic utility, prognostic and/or predictive ability, and those that can potentially be used as surrogate endpoints in clinical trials.

  • DIAGNOSTIC BIOMARKERS
    Including in-vitro diagnostic devices (IVDs) and imaging tools as companion diagnostics for precision medicine

  • PROGNOSTIC BIOMARKERS
    For patient enrichment and selection of treatment strategies

  • PREDICTIVE BIOMARKERS
    For treatment choices and effective implementation of precision medicine

  • RESPONSE, SAFETY and MONITORING BIOMARKERS
    For drug development and clinical use

  • SURROGATE BIOMARKERS
    That can replace clinical endpoints in clinical trials
TALK TO AN EXPERT

LISTEN TO IDDI RECORDED WEBINAR

COMPANION DIAGNOSTICS AND CLINICAL DEVELOPMENT IN ONCOLOGY/ A STATISTICAL PERSPECTIVE
  • This webinar provided a discussion around the need for integration of biomarker and IVD validation in clinical development, with a focus in oncology and companion diagnostics.
  • It highlighted how flawed analytical and/or clinical validation can jeopardize a biomarker’s and drug’s clinical utility and showcase why biomarkers deserved statistical rigor throughout the development and validation process.