Immunohistochemistry (IHC) biomarkers are a key component of today’s drug development process. Precision has experience in developing and validating IHC biomarkers to support many key areas in our CLIA laboratory:
- Evaluate pharmacodynamic effects and therapeutic efficacy
- Patient enrollment and stratification with a 72-hour turnaround time
- Mechanism of action to further understand drug activity
- Predictive and prognostic biomarkers
- Monitor immune response to immunotherapies by profiling key immune cell populations
Immunohistochemistry biomarker assays
At Precision, we understand that tissue samples are limited and you need to maximize the amount of data generated from small amounts of tissue. Our team of scientists can develop, validate, and implement IHC assays to support early stage or exploratory proof of concept studies, through Phase III studies that require a CLIA validated assay.
We handle all aspects of IHC biomarker analysis including:
- Custom assay development, qualification & validation, including scoring system
- Logistical process for sample collection
- Global deployment of custom kitting
- Sample receipt and tissue processing
- Centralized pathology reading with manual scoring by a pathologist or automated software-based scoring
- Real time analysis for patient screening & enrollment (CLIA)
We also can develop an IHC assay into a companion diagnostic.
Couple IHC biomarker assays with our other technologies to generate robust data sets
Clinical biomarkers go far beyond traditional IHC. We offer customized work flows across our integrated platform to generate incredibly rich data sets.
- Look at multiple tissue biomarkers for immunophenotyping with multiplex quantitative immunofluorescence image analysis
- Liquid biopsies offer an alternative when tissues are not available for serial assessment of pharmacodynamic biomarkers
- Leverage our genomics applications to understand the genetics behind the proteomic results
- Immunophenotype blood samples from the same patient via flow cytometry for in depth analysis of the immune system in both the tumor and blood
- Detect chromosomal abnormalities by FISH or mRNA by ISH in the same tissue samples used for IHC
Case Study: Patient stratification using biomarkers from biopsies
Precision developed an IHC assay for patient study enrollment by P-Cadherin expression in tumor biopsies:
- Assay development and customized kitting generation and shipment
- Development of a semi-quantitative IHC scoring index (SI) to compare P-Cadherin staining intensity and prevalence from sample to sample
- IHC pathology analysis by scoring index; rapid turnaround of results reported within 72 hours of receipt
This rapid turnaround of scoring index data enabled P-Cadherin expression to be utilized as a criterion for inclusion in the study.
Representative Images with Scoring Index (SI)
Integrating biomarker and clinical trial data
To help researchers understand and interpret biomarker assay data in the context of other assays as well as the clinical trial data, Precision provides the option of managing and analyzing data using our proprietary QuartzBio Translational Informatics platform.
Global reach, multi-site support
Our IHC services support preclinical and clinical research, including multi-site studies, conducted anywhere in the world.
Working with Precision
Precision’s specialty lab scientists take a collaborative and consultative approach to projects and can provide recommendations on biomarker assay strategies and implementation. Services can be provided individually or as part of a comprehensive therapeutic development package including biomarker assays and clinical trials.
We offer automated multiplex immunofluorescence (mIF) services that enable quantitative visualization of up to 9 markers in tissue and liquid biopsies, and individual cells. mIF can be integrated with other methods including co-analysis using FISH/ISH.
Our in-house pathology team can provide rapid turn-around times, expert assessments, and a full suite of sample processing services including FFPE and microdissection for genomics applications.