• Biospecimen SolutionsPrecision Value & HealthCareers
    P_ForMedicine_no_tag_RGBP_ForMedicine_no_tag_RGBP_ForMedicine_no_tag_RGBP_ForMedicine_no_tag_RGB
    • Clinical
      Trial Services
        • Overview
            • Oncology Clinical TrialsImage

              Oncology Clinical Trials


              Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs.

              • Rare & Orphan DiseaseImage

                Rare & Orphan Disease


                With experience built on 150+ orphan disease projects covering 80+ rare diseases, we know how to anticipate logistical and regulatory obstacles and craft bold solutions that drive rare disease development programs.

        • Global Clinical Trial Support –
            • North & South America –
              • Oncology Clinical TrialsImage

                Oncology Clinical Trials


                Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs.

            • Europe –
              • Oncology Clinical TrialsImage

                Oncology Clinical Trials


                Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs.

            • APAC –
              • Oncology Clinical TrialsImage

                Oncology Clinical Trials


                Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs.

        • Clinical Trial Management –
            • Study Start-up & Feasibility –
              • Oncology Clinical TrialsImage

                Oncology Clinical Trials


                Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs.

            • Project Management –
            • Patient Recruitment –
            • Personalized Clinical Trial Operations –
            • Biometrics –
            • Medical & Safety Monitoring –
            • Clinical Data Management –
            • Medical Writing –
        • Clinical Development Strategy –
            • Clinical Development Planning –
              • Oncology Clinical TrialsImage

                Oncology Clinical Trials


                Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs.

            • Biomarker Strategies –
            • Cell & Gene Therapy Strategies –
            • CDx Regulatory and Market Access –
        • Clinical Trial Design –
            • Basket & Umbrella Trials –
              • Oncology Clinical TrialsImage

                Oncology Clinical Trials


                Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs.

            • Biomarker Clinical Trials –
            • Master Protocol Trials –
            • Decentralized Clinical Trials
        • Biostatistics –
            • Statistical Consulting –
              • Oncology Clinical TrialsImage

                Oncology Clinical Trials


                Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs.

            • Study Design –
            • Data Monitoring Committees –
            • CDISC Programming and Documentation –
            • eCTD Submissions –
        • Central Lab Services –
            • Clinical Specimen Kitting –
              • Oncology Clinical TrialsImage

                Oncology Clinical Trials


                Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs.

            • Sample Processing –
            • Global Specimen Logistics and Biostorage –
            • Biospecimen Data Services –
            • Precision Lab e-Portal –
            • Virtual Sample Inventory Management –
        • Training
            • Oncology Clinical TrialsImage

              Oncology Clinical Trials


              Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs.

              • Rare & Orphan DiseaseImage

                Rare & Orphan Disease


                With experience built on 150+ orphan disease projects covering 80+ rare diseases, we know how to anticipate logistical and regulatory obstacles and craft bold solutions that drive rare disease development programs.

    • Lab
      Services
        • Central Lab Services –
            • Clinical Specimen Kitting –
              • Oncology Clinical TrialsImage

                Oncology Clinical Trials


                Through 20+ years running successful oncology trials, we’ve developed a unique blend of proprietary technologies, flexible processes, and creative problem solving abilities that advance even the most challenging clinical development programs.

            • Sample Processing –
            • Global Specimen Logistics and Biostorage –
            • Biospecimen Data Services –
            • Precision Lab e-Portal –
            • Virtual Sample Inventory Management –
        • Specialty Lab Services Overview –
            • Immune MonitoringImage

              Immune Monitoring


              Leverage sophisticated immune monitoring approaches, including flow cytometry, Epiontis ID immune cell phenotyping, and cytokine profiling, to characterize the immune cells in your samples and understand their impact on patient biology.

              • Tissue & Liquid BiopsyImage

                Tissue and Liquid Biopsy


                Obtain a detailed molecular view into patient biology with a range of tissue and liquid biopsy technologies, including our proprietary ApoStream platform which can isolate and enrich circulating tumor cells for downstream analysis.

        • EU Contract Research Organization –
        • Immune Monitoring –
            • Immune Monitoring by Flow Cytometry –
              • Immune MonitoringImage

                Immune Monitoring


                Leverage sophisticated immune monitoring approaches, including flow cytometry, Epiontis ID immune cell phenotyping, and cytokine profiling, to characterize the immune cells in your samples and understand their impact on patient biology.

            • Immune Cell Phenotyping by Epiontis ID –
            • Cytokine Profiling –
            • Gene Expression Profiling –
            • ELISpot and FluoroSpot –
            • Custom Assays –
        • Flow Cytometry –
            • Immune MonitoringImage

              Immune Monitoring


              Leverage sophisticated immune monitoring approaches, including flow cytometry, Epiontis ID immune cell phenotyping, and cytokine profiling, to characterize the immune cells in your samples and understand their impact on patient biology.

              • Tissue & Liquid BiopsyImage

                Tissue and Liquid Biopsy


                Obtain a detailed molecular view into patient biology with a range of tissue and liquid biopsy technologies, including our proprietary ApoStream platform which can isolate and enrich circulating tumor cells for downstream analysis.

        • Genomics –
            • NanoString Assays –
              • Immune MonitoringImage

                Immune Monitoring


                Leverage sophisticated immune monitoring approaches, including flow cytometry, Epiontis ID immune cell phenotyping, and cytokine profiling, to characterize the immune cells in your samples and understand their impact on patient biology.

            • ddPCR –
            • qPCR –
            • NGS –
            • Fluorescence In Situ Hybridisation (FISH) / ISH –
        • Tissue & Liquid Biopsy –
            • ApoStream – CTC and Rare Cell Isolation for Liquid Biopsy
              • Immune MonitoringImage

                Immune Monitoring


                Leverage sophisticated immune monitoring approaches, including flow cytometry, Epiontis ID immune cell phenotyping, and cytokine profiling, to characterize the immune cells in your samples and understand their impact on patient biology.

            • CTC / cfDNA / Exosome Analysis –
            • Multiplex Immunofluorescence –
            • Immunohistochemistry –
            • Fluorescence In Situ Hybridisation (FISH) / ISH
            • Pathology Services –
            • NanoString Assays
        • Bioanalytical Testing –
            • Immunogenicity Testing –
              • Immune MonitoringImage

                Immune Monitoring


                Leverage sophisticated immune monitoring approaches, including flow cytometry, Epiontis ID immune cell phenotyping, and cytokine profiling, to characterize the immune cells in your samples and understand their impact on patient biology.

            • PK Assays –
            • ADA Assays –
            • MesoScale Discovery (MSD) Assays –
            • Quanterix SIMOA –
            • ELISA
        • Cytokine Analysis –
            • ELISA –
              • Immune MonitoringImage

                Immune Monitoring


                Leverage sophisticated immune monitoring approaches, including flow cytometry, Epiontis ID immune cell phenotyping, and cytokine profiling, to characterize the immune cells in your samples and understand their impact on patient biology.

            • MesoScale Discovery (MSD) Assays
            • Luminex –
            • Quanterix SIMOA
        • Preclinical Target and Biomarker Validation –
            • Cell Based Assays –
            • Target Expression – XpressWay Profiles –
            • Tissue Cross-Reactivity –
            • Fluorescence In Situ Hybridisation (FISH) / ISH –
            • Multiplex Immunofluorescence –
            • Immunohistochemistry (IHC)
        • Biospecimens
            • Immune MonitoringImage

              Immune Monitoring


              Leverage sophisticated immune monitoring approaches, including flow cytometry, Epiontis ID immune cell phenotyping, and cytokine profiling, to characterize the immune cells in your samples and understand their impact on patient biology.

              • Tissue & Liquid BiopsyImage

                Tissue and Liquid Biopsy


                Obtain a detailed molecular view into patient biology with a range of tissue and liquid biopsy technologies, including our proprietary ApoStream platform which can isolate and enrich circulating tumor cells for downstream analysis.

    • Data
      Sciences
        • Overview
            • BiostatisticsImage

              Biostatistics


              Seasoned biostatisticians and statistical programmers support every phase of your trial, from study design for small, rare disease trials to regulatory submissions, all backed by meticulous documentation.

              • Computational BiologyImage

                Computational Biology


                Domain experts from our QuartzBio team utilize integrated and harmonized data and tailored AI solutions to drive preclinical and clinical development, including patient stratification, signature development, predictive modeling of drug response, and MOA characterization.

        • Biostatistics
        • Clinical Data Management
        • Biometrics
        • QuartzBio –
            • Biomarker Data Management –
              • BiostatisticsImage

                Biostatistics


                Seasoned biostatisticians and statistical programmers support every phase of your trial, from study design for small, rare disease trials to regulatory submissions, all backed by meticulous documentation.

            • Virtual Sample Inventory Management –
    • Diagnostics
      & CDx
        • IVD and CDx Regulatory Affairs Consulting –
          • spevialty_labs_slice-300×54Image

            Specialty Lab Services


            Our comprehensive approach starts with a foundation of expertise in key biomaker discovery and analysis methods such as immune monitoring, genomics, and bioanalysis.

        • COVID-19 & Viral Panel Assays –
          • spevialty_labs_slice-300×54Image

            Specialty Lab Services


            Our comprehensive approach starts with a foundation of expertise in key biomaker discovery and analysis methods such as immune monitoring, genomics, and bioanalysis.

        • Biospecimens Solutions 
          • spevialty_labs_slice-300×54Image

            Specialty Lab Services


            Our comprehensive approach starts with a foundation of expertise in key biomaker discovery and analysis methods such as immune monitoring, genomics, and bioanalysis.

        • Diagnostic Market Access Services –
          • spevialty_labs_slice-300×54Image

            Specialty Lab Services


            Our comprehensive approach starts with a foundation of expertise in key biomaker discovery and analysis methods such as immune monitoring, genomics, and bioanalysis.

    • Therapeutic
      Areas
        • Overview
            • By Specialty Area
              • Global-clinical-trial-support-2Image

                Global Clinical Trial Support


                Sample processing labs, clinical trial sites and offices in five continents provide the clinical reach and scale to manage complex global programs.

            • Oncology and Immuno-Oncology
              • Oncology Clinical Trials
            • Rare & Orphan Disease
              • Global-clinical-trial-support-2Image

                Global Clinical Trial Support


                Sample processing labs, clinical trial sites and offices in five continents provide the clinical reach and scale to manage complex global programs.

            • Cell & Gene Therapy
              • Cell Therapy
              • Gene Therapy
              • Cell and Gene Therapy Manufacturing
            • CNS & Neuroscience
              • Global-clinical-trial-support-2Image

                Global Clinical Trial Support


                Sample processing labs, clinical trial sites and offices in five continents provide the clinical reach and scale to manage complex global programs.

            • COVID-19
            • AutoImmune & Allergy
            • Pediatric
            • Companion Diagnostics
        • By Research Phase
        • Preclinical Development –
        • Early Phase Trials (I-IIa) –
        • Late Phase Trials (IIb-III) –
    • News &
      Insights
        • Blog –
            • iStock-945738094Image

              Blog


              Industry trends and best practices from Precision experts

              • shutterstock_1033743346Image

                Resources


                A searchable hub featuring the latest Precision case studies, white papers, capabilities brochures and more.

        • Resources –
        • Thought Leadership –
        • News –
            • iStock-945738094Image

              Blog


              Industry trends and best practices from Precision experts

              • shutterstock_1033743346Image

                Resources


                A searchable hub featuring the latest Precision case studies, white papers, capabilities brochures and more.

        • Events –
            • iStock-945738094Image

              Blog


              Industry trends and best practices from Precision experts

              • shutterstock_1033743346Image

                Resources


                A searchable hub featuring the latest Precision case studies, white papers, capabilities brochures and more.

    • About
      Us
        • Our Passion –
            • Patient RecruitmentImage

              Our Passion


              What we do, why we do it and the principles that guide us every day.

              • meet-our-peopleImage

                Meet Our People


                We are devoted professionals with deep expertise in translational science, clinical trials and data sciences.

        • Meet Our People –
        • Careers
        • Regulatory Information –
            • Patient RecruitmentImage

              Our Passion


              What we do, why we do it and the principles that guide us every day.

              • meet-our-peopleImage

                Meet Our People


                We are devoted professionals with deep expertise in translational science, clinical trials and data sciences.

    • Contact
      Us
    • Home
    • News & Insights
    • Case Studies
    • Development of an IHC-Based Assay for Detection Of P-Cadherin in Tumor Tissue

    Development of an IHC-Based Assay for Detection Of P-Cadherin in Tumor Tissue

    Clinical Application: Patient Selection for Enrollment

    Key Words: patient stratification, tumor biopsies, quantitative IHC

    Background: Personalized medicine is an emerging idea in health care; the ability to determine a patient’s responsiveness to a given treatment in advance, through real-time testing, would be useful for many. In this particular case, ApoCell helped to assess the feasibility of using an immunohistochemical (IHC) assay for P-cadherin, a cellular adhesion protein that is thought to contribute to the oncogenesis of many types of cancers, as a means of patient selection for an ongoing Phase I clinical trial. Each patient’s P-cadherin expression level was then quantified using immunofluorescence (IF), and was evaluated as a correlative measure with clinical outcome.

    Methods: ApoCell first tested and finalized an IHC assay and reagent kit that would be used by each trial site for testing. Tumor biopsies were then obtained from 94 patients, from three sites world-wide. Each trial site ran independent IHC assays using kits provided by ApoCell, conducted analyses by board-certified pathologists, and provided both their IHC-stained slides and additional unstained archival biopsy slides for analysis by ApoCell. A scoring index (SI) was used to evaluate P-cadherin positivity (see Figure 1); an SI of greater than or equal to 4 was associated with poor clinical outcome, and was chosen as one criterion for inclusion into the trial.

    Figure 1. SI for P-Cadherin staining. IHC slides were scored for P-Cadherin positivity using a product of the area score (a measure of the total tumor tissue positive for P-Cadherin) and the intensity score (a measure of staining intensity. An SI of greater than or equal to four was chosen as one of the criteria for inclusion into the trial. Figure 2. Representative Imager of P-Cadherin IHC Staining.  The images above illustrate typical images of P-Cadherin staining at the specified SIs. The top row represents P-Cadherin stained-tissue; the bottom row represents examples of paired negative controls. Figure 3. P-cadherin IHC Scoring Summary. Using the SI system,
    a total of 65 of 94 (69.2%) patients were found to be P-cadherin
    positive, and thus eligible for inclusion into the trial. Good agreement (86 of 94 patients; 91.5% concordance rate) was
    found in the scoring of the IHC slides between the trial sites and ApoCell, indicating consistency and reproducibility of the method for future applications.

    Impact: This study indicates the feasibility of prospectively selecting patients based on IHC expression of P-cadherin using a custom standardized scoring index analysis across
    multiple clinical sites. It also indicates that such methods could theoretically be applied to other biomarkers and other cancer types as well. Being able to analyze the expression
    levels of certain biomarkers – specifically, examining particular drug targets, and evaluating the efficacy of a treatment prior to administering it – within a patient’s tumor with
    relative haste could easily lead to an improvement in many patients’ prognosis.

    References: 1. Davis DW, et al. “Prospective Real-Time Analysis of P-cadherin Expression to Select Patients into a Phase I Oncology Trial.” EORTC-NCI-AACR, 2009.

     

    Precision for Medicine is part of the Precision Medicine Group, an integrated team of experts that extends Precision for Medicine’s therapeutic development capabilities beyond approval and into launch strategies, marketing communication, and payer insights. As one company, the Precision Medicine Group helps pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.

    Visit the website
    Clinical Trial Services
    • Overview
    • Global Clinical Trial Support
    • Clinical Trial Management
    • Clinical Development Strategy
    • Clinical Trial Design
    • Biostatistics
    • Clinical Sample Management
    • Clinical Research Organization
    Specialty Lab Services
    • Overview
    • Immune Monitoring
    • Flow Cytometry
    • Genomics
    • Tissue & Liquid Biopsy
    • Bioanalytical Testing
    • Cytokine Analysis
    • Biospecimens
    • Sample Processing
    • Global Specimen Transport & Biostorage
    • Contract Research Organization
    • Bioanalysis
    • Neutralizing Antibody (NAb) Assays
    • PBMC Processing
    Data Sciences
    • Overview
    • Biostatistics
    • Clinical Data Management
    • Biometrics
    • QuartzBio
    • Virtual Sample Inventory Management
    Therapeutic Expertise
    • Overview
    • Preclinical Development
    • Early Phase Trials (I-IIa)
    • Late Phase Trials (IIb-III)
    • Oncology and Immuno-Oncology
    • Rare & Orphan Disease
    • Cell & Gene Therapy
    • Neurology
    • COVID-19
    • Autoimmune & Allergy
    • Pediatric
    • Companion Diagnostics
    About Us
    • Our Passion
    • Meet Our People
    • Careers
    • ESG Policy
    • Regulatory Information

    News & Insights
    • Publications
    • Case Studies
    • Thought Leadership
    • News
    • Events
    © 2023 Precision Medicine Group, LLC. All rights reserved. Privacy Policy    GDPR