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    In-Vitro Diagnostics

    In-vitro diagnostics (IVD) and companion diagnostics (CDx) are at the forefront of today’s patient-centric medical breakthroughs. In these competitive environments, smart partnerships make a critical difference.

    At ProMedDx, we work closely with you to help ensure the success of your IVD and CDx programs.

    Whether you are validating an existing assay on a new platform or challenged with developing a companion diagnostic (CDx) for a new drug or biologic, you can trust ProMedDx expertise to deliver the highest-quality biologics and supporting clinical research services that keep your project on-time and within budget.

    Closing the Gap Between Biologics Demand and Delivery

    ProMedDx simplifies the challenges of assay development, helps you achieve your objectives faster, and supports the success of your IVD and CDx programs with these vital services:

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    The BioRepository

    The BioRepository at ProMedDx is purpose-built for IVD. It contains more than one million IRB-approved, clinically annotated biospecimens – including human serum, plasma, whole blood, urine, FFPE and fresh frozen tissue – all available for next-day delivery to your lab to accelerate the progress of your research.

    • Correlation Specimens
    • Healthy Cohort
    • Diagnosed (Clinical) Specimens
    • Bulk Units
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    Prospective Collections

    When your project requires biospecimens that are unique or not readily available, ProMedDx provides you with a solution that is as easy as a phone call or email. Our team of GCP- and cGMP-experienced project managers will work with you to determine the precise biospecimens required, and match those requirements to our network of IRB-approved investigators for recruitment and collection. Leverage ProMedDx expertise in protocol development, specimen collection, and cold chain logistics to ensure you have the critical biospecimens to complete your research and clinical trials.

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    Sample Storage and Distribution

    You have invested time, energy, and resources collecting your specimens. Do you have the staff, infrastructure, expertise, or resources you need to manage them? ProMedDx biostorage – our continuously monitored, state-of-the-art specimen management, storage, and distribution service – offers you the accessibility of an onsite biobank with the security and confidence available only from a cGMP-compliant biostorage provider. Contact us and discover how simple and affordable it is to take advantage of compliant, traceable, and secure ProMedDx biostorage.

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    Specimen Processing

    At ProMedDx, we do more than collect and store samples. Our cGMP-compliant bioprocessing services laboratory is equipped to prepare biospecimens to your exact specifications. Custom labeling, cell extraction, aliquoting, dilution panels, or additional characterization are just a few of the many specimen processing requests we have fulfilled at our facility. ProMedDx has the infrastructure, procedures, and proven expertise in formatting your specimens for easy integration into your research and clinical studies.

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    "ProMedDx’s team support and Biorepository has allowed us to quickly troubleshoot, identify, and respond to client observed performance of our testing systems.”

    - Senior Quality Project Engineer, European-based global provider of Diagnostic Assays