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Custom Assay Development & Innovation (CADI) Services: Discover the Possibilities

Drive your research from discovery to clinical trials with our Custom Assay Development & Innovation (CADI) services and our highly skilled team of scientists. We will work closely with you to develop a work plan that meets the scope of your project then we will adhere to the highest quality standards to provide a custom immunoassay solution designed specifically for your research needs. Whether you require MILLIPLEX® multiplex, ELISA, or ultrasensitive Single Molecule Counting (SMC®) assay development or sample testing on our SMCxPRO® platform, CADI is here to help.
Two scientists in a lab performing immunoassay work on the SMCxPRO® instrument with the Luminex® xMAP® INTELLFLEX® instrument in the background.

Custom Assay Development & Innovation (CADI) Services

Assay Development

Our assay development services include traditional custom assay development for ELISAs, multiplex MILLIPLEX® assays, and ultrasensitive SMC® assays, as well as reconfiguring analytes from our existing MILLIPLEX® multiplex panels.

Reconfigured Analytes From Existing MILLIPLEX® Multiplex Panels

Our Special Product Release (SPR) program allows you to combine analytes from up to three panels without completing a custom assay development request or creating a work plan. Instead, your local immunoassay specialist will submit your list of analytes for a feasibility review that leverages our knowledge base of pre-verified analyte/panel combinations.

If the combination is feasible, we combine off-the-shelf kit components from multiple existing MILLIPLEX® panels to create the mix of analytes you need. High/low quality control (QC) range values are also available for an additional testing fee.

Custom Assay Development

We understand you do not always have the time or resources to develop your own custom assay for your protein(s) of interest. For any immunoassay requiring new analyte development or any reconfigured MILLIPLEX® assays with more complex combinations (analytes from 4 or more existing panels), you will partner with your local sales specialist and a member of the CADI team to define the project scope. We then review the feasibility based on reagent availability for new analyte development and compatible sample dilution, matrix, sample preparation requirements, and known analyte cross-reactivity for new mixes of MILLIPLEX® analytes/panels.

After the feasibility review, you receive a quote outlining the milestone-based approach we will take to generate a robust fit-for-purpose MILLIPLEX®, ELISA, or SMC® immunoassay that accurately and reliably quantifies your target biomarker(s) for you. At each milestone you will participate in data reviews, giving you the peace of mind that your project is on schedule and meeting specifications.

Milestones

Source, screen, and select antibodies and standards for new analyte(s)

CADI Feasibility

Source, screen, and select antibodies and standards for new analyte(s)

    Generate standard curve. Plex with other new or existing analytes (MILLIPLEX® only). Estimate sensitivity. Assess cross-reactivity
    • Generate standard curve
    • Plex with other new or existing analytes (MILLIPLEX® assays only)
    • Estimate sensitivity
    • Assess cross-reactivity
      Verify assay as needed by client (e.g., intra-/inter-assay %CV, spike recovery, dilution linearity, parallelism, cross-reactivity/interference testing, and assay/sample stability testing)
      • Adjust standard curve range
      • Determine sample dilution factor
      • Optimize reagents
        Verify assay as needed by client (e.g., intra-/inter-assay %CV, spike recovery, dilution linearity, parallelism, cross-reactivity/interference testing, and assay/sample stability testing)

        Verify assay as needed by client (e.g., intra-/inter-assay %CV, spike recovery, dilution linearity, parallelism, cross-reactivity/interference testing, and assay/sample stability testing)

          Produce kit containing all necessary components plus a customized protocol

          Produce kit containing all necessary components plus a customized protocol

            Ultimately we aspire to provide the quality and ease of use you expect from an immunoassay. To that end, we offer additional assay development options to take your program from discovery research to clinical trials:

            • Different formats
              • Switch an existing MILLIPLEX® antibody pair to the SMC® platform when greater sensitivity is needed
              • Convert an existing MILLIPLEX® assay from 96-well to 384-well or select a 384-well format for your custom assay
              • Choose a bead-based or a plate-based SMC® custom assay format
            • Custom reagents*
              • High/low QCs with range values
              • Premixed beads
              • Bead re-conjugation to resolve bead region conflicts
            • Real sample testing during development
              • With client-provided samples, so we can test in-house throughout development
              • With test kits sent to customer for their evaluation

            *Additional fees may apply.

            Additional Biomarker Development and Detection Capabilities

            In addition to custom assay development, our CADI capabilities include biotherapeutic discovery, custom reagents and packing, and sample testing services.

            Biotherapeutic Discovery

            The ability to assess safety and performance quickly and accurately is critical to the development of biotherapeutics. The high sensitivity SMC® technology accelerates this development via custom assays for:

            Custom Reagents and Packaging

            When you want premixed beads to conserve assay set-up time or would like individual components or custom pack sizes for automation or to maximize limited storage space, the following options are available:

            • Custom antibody*-coated beads/magnetic particles
            • Custom labeled detection antibodies*
            • Bulk or custom pack sizes for MILLIPLEX® components and/or SMC® components
            • Premixed beads for MILLIPLEX® assays without premixes or custom premix part numbers

             *Client-provided antibodies or CADI-sourced and screened antibodies.

            Sample Testing

            We offer non-CLIA/non-GLP, fit-for-purpose sample testing for custom and commercially available assays on the SMC® platform to evaluate potential biological relevance in real samples and to identify biological anomalies that may occur due to drug interference or matrix effect. Connect with your local sales specialist to request a quote for a sample testing project or to try our SMCxPlore Proof of Concept (POC) Sample Testing service. With this introductory assay service, we will test up to 30 of your critical samples using one of our highly verified commercially available kits to demonstrate how SMC® technology meets your experimental needs.

            The SMC® High Sensitivity miR-122 Liver Injury Detection Assay is the latest addition to our sample testing menu. This early-access kit enables the quantification of miR-122 in your serum, plasma, and cell media supernatant samples with minimal hands-on steps. Watch this webinar to see how SMC® technology is being used in toxicity studies to enable early and accurate detection of low-abundant miR-122, a specific and sensitive biomarker that can be used to evaluate drug safety profiles earlier in drug development to minimize financial loss from late-stage failure.

            Contact your local sales specialist to take advantage of this service by filling out the form on our CADI page.

            Note: All custom assays and reagents are intended for research use only (RUO) and are not to be used for any other purpose, which includes but is not limited to, unauthorized commercial uses, in vitro diagnostic uses, ex vivo or in vivo therapeutic uses or any type of consumption or application to humans or animals.

            CADI: The Custom Assay Development Partner You Trust

            Why should you partner with CADI to help advance your research? In addition to our proven assay development expertise across multiple immunoassay platforms, we pride ourselves in offering white-glove service. Learn how our custom assays accelerated pediatric lupus research in the video below.

            Proven Assay Development Expertise Across Multiple Platforms

            With decades of immunoassay development expertise, we are committed to delivering the best possible immunoassays for your research needs. Whether you require a MILLIPLEX® multiplex panel to broadly survey multiple analytes, femtogram/mL biomarker analysis using the Single Molecule Counting (SMC®) ultrasensitive immunoassay platform, or single protein detection with a tried-and-true ELISAs, you can confidently expect a knowledgeable scientific partner to create an assay that generates reliable measurements to help drive your biomarker project from hypothesis to publication.

            Scientific Partnership With White-Glove Service

            From beginning to end your journey will be an interactive, iterative process as you work closely with our team to define your requirements and fulfill your research goals. Throughout the project, you will receive incremental progress updates and have easy direct access to the scientific team for questions and discussions related to the project. These collaborative milestone reviews confirm your specifications and schedule are met.

            We also support requests for additional documents such as:

            • Confidentiality/non-disclosure agreements
            • Service agreements
            • Time-delimited analyte/kit exclusivity agreements

            Capabilities Beyond The Science

            In addition to our assay development and sample testing expertise, we can leverage other areas within our global organization. For researchers requiring reproducible production under our quality systems and additional supply chain security, we can transfer assay production from our R&D team to our ISO 9001 certified Manufacturing site. And for researchers interested in co-development projects to commercialize new biomarkers, our expansive supply chain provides access to researchers worldwide.

            You can also take advantage of other products within our Life Science portfolio to drive scientific breakthroughs.

            Request Info on Custom Services

            Curious about our CADI capabilities and services? Click the button below to request more information or contact your local sales specialist. The CADI team is happy to discuss how our extensive experience can meet your immunoassay needs. You can also find answers to common questions on our CADI FAQs page

            For Research Use Only. Not For Use In Diagnostic Procedures.


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