Biomarkers Solutions
Providing Genomic Insights and Biomarker Discovery to Improve Trial Outcomes
Biomarker use in clinical drug development programs is a growing necessity for many treatment areas. To help our clients improve clinical trial success rates, we offer a wide range of robust biomarker solutions.
The integration of clinical information and drug discovery is critical to developing and supporting customized clinical solutions for patient stratification and treatment selection.
Clinical research relies on diverse techniques and methodologies to test for biomarkers that are key to identifying the ‘right patient for the right drug’. The development of comprehensive biomarker strategies can be crucial to the clinical and commercial success of your development program.
Interpace Pharma Solutions (IPS) develops, tests and works with our clients to integrate biomarkers into their clinical development programs.
Start Your Biomarker Strategy Development with Interpace Pharma Solutions
We help optimize clinical trials by using biomarkers to improve selection or exclusion of patients for therapy or dose adjustment, to demonstrate efficacy or detect toxicity. Finding the right patients faster reduces trial costs and helps speed new treatments to targeted patient populations.
Biomarkers in Clinical Trials
In clinical trials, biomarkers serve a range of practical uses:
- Screening of patients for eligibility
- Stratification into subgroups
- Monitoring of responses
- Correlative studies for future reference
Our clinical trial customers have access to our extensive line of proprietary tests for hematological and solid-tumor cancers, as well as a full range of off-the-shelf assays.
Biomarker Use In Clinical Trials For Cancer Treatments
The growth of research and development in cancer immunotherapies continues to accelerate the need for the technology-agnostic, multi-omic services that have become fundamental to cancer research.
There is also an increasing focus on pan-tumor biomarkers, such as PD-L1. Interpace Pharma Solutions has extensive experience with PD-L1 and has validated assays for all commercially available PD-L1 clones across multiple indications
Interpace Pharma Solutions also offers an extensive portfolio of genotyping services, with access to more than 250 validated genotyping assays including Phase I and Phase II drug-metabolizing enzymes, transporters, and receptors, and more than 30 validated gene expression assays.
We know that when it comes to clinical trials, time is of the essence! We provide time-sensitive trial test development, rapid proof-of-concept studies, and dependable results from early-phase initiatives.
Biomarker Challenges in Clinical Research
Our biomarker services are designed to help our clients overcome common issues associated with:
- Sample processing and tracking
- Changing technologies
- Biomarker misclassification
- Collaboration and communications between clinicians and laboratory
- Research and development of biomarker strategies
Interpace Pharma Solutions Can Help Across All Stages of Clinical Development
Technologies and Services to Support Your Biomarker Strategies
Nucleic Acid Extraction and Purification
Pharma Solutions offers extensive expertise with nucleic acid extraction and purification. We utilize state-of-the-art automation and skilled technicians to extract and isolate DNA and RNA from a wide variety of sample types in our CLIA-certified, GLP-compliant laboratory. Our systems are fully scalable to accommodate the needs of all clinical trials.
Gene Expression and Mutation Detection Analysis
Our scientists have extensive experience working with clients to develop optimal study designs, sample collection protocols, and strategic application of gene expression in clinical studies. We work with our clients to identify the molecular signature of a disease, correlate to a pharmacodynamic marker, and ensure a dose-dependent cellular response to drug exposure
IPS provides high quality genotyping services for clinical trials, and adheres to stringent regulatory standards including GLP, CLIA, and GCP.
Our scientific teams work with clients to choose the clinically relevant genes and variants, providing them with customizable, attention-driven service. Our strategy is to be “platform agnostic”, providing the best solution for a complete range of client needs.
If an assay for a particular gene or polymorphism is not available, our highly experienced staff ensures the development and validation of new and custom assays.
Pharma Solutions offers an extensive suite of NGS services to meet any demand, including hypothesis-free studies, turn-key solutions with actionable content for diagnosis/prognosis/risk stratification, as well as fully customizable panels built to specification with the help of our highly trained and experienced team of bioinformaticists and scientists.
NanoString is a leading provider of life science tools for translational research and molecular diagnostic products. The Nanostring nCounter® Analysis System is used in life sciences research to profile the expression of hundreds of genes, proteins, miRNAs, or copy number variations, simultaneously with high sensitivity and precision, including biomarker discovery and validation.
The GeoMx® Digital Spatial Profiler enables highly-multiplexed spatial profiling of RNA and protein targets in a variety of sample types, including FFPE tissue sections.
Interpace Pharma Solutions can support both nCounter and GeoMx DSP platforms to support your study needs.
Immunohistochemistry (IHC)
Interpace Pharma Solutions provides full IHC capabilities accommodating a variety of analyses utilizing various platforms. Our state-of-the-art IHC laboratory is equipped with modern automation and advanced capabilities, including digital pathology.