Definiens Releases Biomarker Datafication Services for Oncology Clinical Development
New Offering Announced at ASCO 2015 Provides Valuable Data for Clinical Program Decision Making
MUNICH- Definiens, the global leader in image analysis for digital pathology and diagnostics, today announced a new suite of Biomarker Datafication Services for oncology clinical development programs. This package of services enables pharmaceutical and biotech companies to gather comprehensive data from their tissue samples which can be used to make critical decisions on drug candidate advancements and assess the potential of companion diagnostics for patient stratification.
“This empowers our customers to accelerate their clinical development planning by gaining increased confidence in the markers and indications to move into preclinical or Phase I trials.”
“Biomarker projects are critical to drug development programs and are essential in demonstrating a therapy’s medical value, but it can be challenging to determine which biomarkers or indications to move into clinical development,” said Merrilyn Datta, President, Definiens. “The Biomarker Datafication Services package is Definiens’ solution for the clinical development market. It enables researchers working with human tissue samples to define cutpoints for patient stratification, such as clearly defining the complex contextual relationships in the tumor microenvironment that are relevant to patient response. Ultimately this tool provides researchers with better data so they can be sure they’re moving the biomarkers and indications with the highest probability of success into clinical trials.”
The Biomarker Datafication Services support data gathering and analysis for researchers working on projects in Exploratory Screening, Pharmacokinetics/Pharmacodynamics, and Companion Diagnostic development. By providing high quality image analysis screening for fast and quantitative measurement, users can receive powerful data output including biomarker expression profiles, biological response to therapy and continuous biomarker readouts, allowing highly advanced decision making and data analysis. Specific benefits include:
Exploratory Screening
Definiens’ Biomarker Datafication Services provide preliminary image analysis screening for fast and quantitative measurements to compare biomarker expression profiles across indications, enabling researchers to determine the strongest biomarker signals for clinical development and companion diagnostics.
Continued Merrilyn Datta, “This empowers our customers to accelerate their clinical development planning by gaining increased confidence in the markers and indications to move into preclinical or Phase I trials.”
Pharmacokinetics/Pharmacodynamics
Researchers need to establish or confirm that a therapy reaches the tumor and affects the pathway as anticipated in order to support a Phase II trial investment. Definiens’ solution provides quantitative image analysis measurements of biological responses to therapy in Phase I, giving pharmaceutical and biotech companies a thorough understanding of therapy performance before investing in Phase II.
Companion Diagnostics
Verifying biomarker selection, identifying optimal cutpoints for an assay and assessing the potential of a biomarker for stratifying patients prospectively are critical to the development of companion diagnostics.
Definiens’ high quality, accurate automated image analysis solution provides quantitative and continuous biomarker readouts. This enables researchers to confirm biomarker selection, optimize test specificity and sensitivity to overcome biological and staining variability, and identify cutpoints for stratification.
“The Biomarker Datafication Services provide a highly accurate, automated solution for identifying and validating biomarkers, understanding the affect of early stage therapies and developing crucial companion diagnostics,” said Merrilyn Datta, “Ultimately this enables pharmaceutical and biotech companies to identify the right patients who will benefit from a therapy, resulting in stronger clinical trial data for more successful clinical programs.”
Learn more about Definiens’ Biomarker Datafication Services at www.definiens.com.
About Definiens
Definiens is the leading provider of image analysis and data mining solutions for diagnostics and clinical digital pathology. Definiens technology provides detailed cell-by-cell readouts from target structures on tissue slides and allows the correlation of this information with data derived from other sources, generating new knowledge and supporting better decisions in research, diagnostics and therapy. Definiens’ Tissue Phenomics approach was awarded the 2013 Frost and Sullivan Company of the Year Award for Global Tissue Diagnostics and Pathology Imaging. For more information, please visit: www.definiens.com.
