Diagnostic Development

ResearchDx has unparalleled experience in developing custom diagnostic assays for your discovery, pre-clinical, and clinical studies. Our team of molecular and cellular biologists provides tailored assay development services to customers worldwide, including diagnostic, biotechnology, and pharmaceutical companies as well as academic researchers. We are experienced in assay development and validation at all stages of the process, from concept and discovery through to final validation, and can support your assay development needs from any point along the way. Our teams are highly skilled in an array of technologies including DNA sequencing (Sanger and Next-Gen technologies), gene expression (Microarray, fluid array technologies Digital and Quantitative PCR), genotyping (SNPs and gross chromosomal abnormalities), flow cytometry, and ELISA. Whether your project includes testing one or ten thousand samples, we are equipped with multiple platforms to reliably meet your needs.

PRE-CLINICAL DEVELOPMENT

ResearchDx can utilize several screening technologies to power your pre-clinical development program. While we are happy to customize any approach to our client’s needs. Popular options for establishing a biological baseline include:

  • Customized evaluation of enzyme activity and inhibition
  • Inhibitor screening and validation
  • Drug compound detection
  • Investigations on reversibility of enzyme inhibition
  • Substrate profiling analyzing selectivity of enzymes and other proteins
  • NGS panel, exome, and whole Genome analysis
  • Transcriptome analysis
  • Flow Cytometry, Multiplex ELIZA and Mass-Spec screening.
  • Multiplex QPCR panels
  • DNA Sequencing
  • LDT (LABORATORY DEVELOPED TEST DEVELOPMENT)

    Regulatory authorities are increasingly requesting that diagnostic studies be conducted under the more stringent CLIA regulations. Through our subsidiary, Pacific Diagnostics, we can design and clinically validate custom assays specific for a clinical study, in less than a third of the time of our competitors, and at under half the cost. We’ve even pioneered technologies, developing a four-color RET/PDGFR?/KIT/CC4 FISH probe.

    We Validate Assays on any of these Widely-used Platforms and More

    iontorrent QIAgen thumbnail-illumina-logo-cmyk
    Beckman Coulter biocare-medical-squarelogo-1399057016908
    Life Technologies Roche RainDance Technologies
    Affymetrix Applied Biosystems Logo_Menarini_Silicon_Biosystems_300
    Agilent
    MultiOmyx SureSelect Ventana

    KIT DESIGN AND COMMERCIALIZATION:

    Through our Custom Diagnostics division, we offer flexible kit and reagent manufacturing to meet your business need. Services include:

    Reagents: We can manufacture reagents under GMP conditions and provide certificates of analysis where required. Typically our reagents are used for specific pre-clinical and clinical diagnostic studies, although our customers have found many other unique and interesting uses.

    Sample Collection Kits: We can provide a GMP/GLP environment for the manufacture and distribution of your specialized sample collection kits to meet your needs.

    Custom Diagnostic Kits: We will ensure a safe GMP/GLP environment for the manufacture and distribution of your specialized diagnostic assays.

    Product Manufacturing: Custom Diagnostics can be an Original Equipment Manufacturer of reagents, kit components, or entire diagnostic assays.

    KEY FEATURES:

    Strong Scientific Support:  Each project is carefully evaluated and designed by experienced PhD-level scientists, and all projects have a dedicated project manager.

    Fast Turnaround:  ResearchDx specializes in rapid assay development, often cutting our competitors expected development times in half without compromising quality or compliance.

    Technology Independence:  ResearchDx works for you. We do not sell instruments, nor receive a commission from instrument manufacturers. We remain platform agnostic, continuously evaluating new technology and instrumentation to ensure that our assays exceed all design specifications.

    Validation and Quality Assurance:  Our assays undergo rigorous analytical and clinical validation, exceeding the specific regulatory guidelines set by CLIA/CAP and the FDA (GMP, GLP, GCP).

    Broad Range of Development Capabilities:  Our development capabilities include a variety of approaches including IHC, Flow Cytometry, Sanger sequencing, quantitative RT-PCR, array CGH, and Next-Gen sequencing technologies. We strive to provide the technology options best suited to meet the needs for biomarker detection/quantification and everything beyond.

    TO SCHEDULE A CONSULTATION, CALL US AT 1-866-225-9195 OR EMAIL info@pacificdx.com