• 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.

        • Companion Diagnostics
    • 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
        • 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
    • ApoCell Awarded $2.9 Million from SAIC-Frederick Inc.

    ApoCell Awarded $2.9 Million from SAIC-Frederick Inc.

    ApoCell awarded $2.9 million from SAIC-Frederick Inc. to deliver a new platform for detection and molecular analysis of circulating tumor cells (CTCs) to the National Cancer Institute’s Pharmacodynamics Program

    HOUSTON (Aug. 10, 2011) —ApoCell, Inc. announced the award of a $2.9 million contract from SAIC-Frederick Inc. (SAIC-F), in support of the National Cancer Institute, for the development and delivery of 12 alpha prototype units of the ApoCell DEP-FFF circulating tumor cell (CTC) detection system, called ApoStream™. The project, funded by the American Recovery and Reinvestment Act (ARRA), is for the delivery of technology for CTC capture and analysis to determine the effects of targeted cancer therapies.

    This is the first commercial order for this revolutionary new cancer diagnostic device and ApoCell expects to deliver the alpha prototype units to SAIC-F for NCI use by early 2013.

    Circulating tumor cells (CTCs) have long been known to exist in cancer patients’ blood. Correlation has been established between the number of CTCs and disease progression. The promise of clinical application of CTCs has not been achieved because these cells are very rare and difficult to detect and analyze using current molecular biology techniques. Current technology depends on the presence of the EpCAM antigen on the surface of the CTCs.

    ApoStream™ employs a process called dielectrophoresis field flow fractionation (DEPFFF), which uses a low level electrical field of varying frequencies to enable the separation of cancer cells in blood. This process has been shown to detect and select significant quantities of circulating cancer cells from small quantities of blood, including rare cell types that have previously gone undetected. Further, ApoStream™ captures the cells alive and viable for additional analytical testing.

    This new technology, which was invented by scientists at The University of Texas MD Anderson Cancer Center’s Laboratory of Diagnostic Microsystems and licensed exclusively to ApoCell, has promising implications in the advancement of cancer research and treatment. It is expected to allow for greater selection and specificity in several different areas, including presymptomatic diagnosis, disease stratification and treatment selection as a function of the stage of progression along with the type of cancer. It will also be beneficial in monitoring cancer therapy and assessing treatment effectiveness. Once approved, this new diagnostic system is expected to be especially useful in detecting hard-to-treat cancers at an early stage, when treatment might be more effective.

    ApoStream™ will play a transformational role in the development of targeted therapies for the prevention and treatment of cancer.

    ApoCell is a pioneer in biomarker analysis and is one of the first commercial laboratories to investigate the effects of drugs in development using CTCs obtained from the blood. ApoCell President and CEO Darren Davis, Ph.D., said, “The award of this contract and its implications in the future of cancer drug development is a great achievement for our dedicated group of scientists and product developers. We are very excited and committed to exceeding NCI/SAIC expectations. This contract allows us to accelerate the manufacture and delivery of the first commercial research use instruments with our ApoCell DEP-FFF technology and our development of clinical FDA-approved diagnostic devices to enable oncologists to implement personalized medicine.”

    While the ApoStream™ device promises advancements in cancer detection, there is no guarantee that the device or its technology will increase cancer survival rates or improve a patient’s quality of life.

    About ApoCell
    Based in Houston, Texas, ApoCell (www.apocell.com) is a privately-held specialty clinical research company. Founded in 2004, the firm is a leader in molecular biomarker detection and analysis and leverages its expertise in the areas of oncology, diabetes, molecular diagnostics and drug development to measure biomarker signatures in clinical trial subjects. The company’s proprietary methods provide early proof of mechanism of action and monitor the effectiveness of various types of drugs by measuring biomarker expression patterns in biopsies, blood and rare cell types. The company’s facilities are CLIA-certified and compliant with applicable FDA regulations. Since inception, the company has participated in over 120 Phase I, II, and III clinical cancer drug trials for more than 80 sponsor clients worldwide.

    About SAIC-Frederick Inc.
    SAIC-Frederick, a wholly owned subsidiary of SAIC, is the operations and technical support contractor for the National Cancer Institute at Frederick — a U.S. national laboratory — focused on speeding up the delivery of new technologies and treatments to patients with cancer and AIDS. SAIC-Frederick’s staff conducts basic research and maintains a full suite of advanced technologies in areas such as nanotechnology, genomics and imaging. The company operates the federal government’s drug and vaccine manufacturing facilities; operates the high-performance Advanced Biomedical Computing Center; manages a nationwide program to improve research and care for the underserved in their home communities; and supports more than 300 clinical trials for patients in the United States and around the world.

    Contacts:
    Carbonara Group
    Cherri Carbonara, cherri@carbonaragroup.com
    Kristin Taylor, kristin@carbonaragroup.com

    Share

    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