[Skip to Content](https://www.sigmaaldrich.com#main-content) [](https://www.sigmaaldrich.com/US/en) Products Cart0 USEN Products [Login / Register](https://www.sigmaaldrich.com/oidc-sign-in) [Order Lookup](https://www.sigmaaldrich.com/US/en/order-lookup) [Quick Order](https://www.sigmaaldrich.com/US/en/quick-order) Cart0 [Home](https://www.sigmaaldrich.com/US/en)[SMC® High Sensitivity Immunoassay Kits](https://www.sigmaaldrich.com/US/en/products/protein-biology/immunoassay-platform-solutions/single-molecule-counting-technology)Custom Assay Development & Innovation | Custom Services for Immunoassays # 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 SMC® assay development or sample testing on our FemtoQuest™ system, CADI is here to help. __Section Overview__ - [](https://www.sigmaaldrich.com)[__Assay Development__](https://www.sigmaaldrich.com#assaydevelopment) - __[](https://www.sigmaaldrich.com)[Additional Biomarker Development and Detection Capabilities](https://www.sigmaaldrich.com#biomarker)__ - __[](https://www.sigmaaldrich.com)[CADI: The Custom Assay Development Partner You Trust](https://www.sigmaaldrich.com#cadi)__ - __[](https://www.sigmaaldrich.com)[Request Info on Custom Services](https://www.sigmaaldrich.com#requestinfo)__ [Request Info on CADI Services](https://www.sigmaaldrich.com/US/en/services/custom-products/custom-milliplex-multiplex-assays-and-elisas)  Custom Assay Development & Innovation (CADI) Services ## [](https://www.sigmaaldrich.com)Assay Development Our assay development services include traditional custom assay development for ELISAs, multiplex MILLIPLEX® assays, and ultrasensitive SMC® single analyte and dual-plex assays, as well as reconfiguring analytes from our existing MILLIPLEX® multiplex panels. ### Reconfigured Analytes From Existing MILLIPLEX® Multiplex Panels We understand that 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 factors including compatible sample dilution, matrix, sample preparation requirements, and [known analyte cross-reactivity](https://www.sigmaaldrich.com/US/en/technical-documents/product-supporting/milliplex/tips-tricks-species-cross-reactivity) for new mixes of MILLIPLEX® analytes/panels. 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](https://www.sigmaaldrich.com/US/en/technical-documents/product-supporting/milliplex/tips-tricks-species-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  ### CADI Feasibility Source, screen, and select antibodies and standards for new analyte(s)  ### CADI Prototyping - Generate standard curve - Plex with other new or existing analytes (SMC® dual-plex and MILLIPLEX® assays only) - Estimate sensitivity - Assess cross-reactivity  ### CADI Development - Adjust standard curve range - Determine sample dilution factor - Optimize reagents  ### CADI Verification 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)  ### CADI Manufacturing 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. ## [](https://www.sigmaaldrich.com)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: - [Immunogenicity](https://www.sigmaaldrich.com/US/en/technical-documents/product-supporting/smc-technologies/high-sensitivity-immunogenicity-assays-overcome-ada-detection-challenges) - [Pharmacokinetics](https://www.sigmaaldrich.com/US/en/technical-documents/product-supporting/smc-technologies/how-ultrasensitive-biomarker-detection-platforms-accelerate-drug) - [Pharmacodynamics](https://www.sigmaaldrich.com/US/en//technical-documents/product-supporting/smc-technologies/high-sensitivity-immunoassays-in-pk-pd) - [Micro-dosing and toxicology studies](https://www.sigmaaldrich.com/US/en/technical-documents/product-supporting/smc-technologies/early-detection-of-cardiotoxicity-biomarkers) ### 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* - Premixed beads for MILLIPLEX® assays without premixes or custom premix part numbers - Bulk or custom pack sizes for MILLIPLEX® components - Bulk or custom SMC® components to support end users’ in-house assay development\** \*Client-provided antibodies or CADI-sourced and screened antibodies. \*\*Restrictions may apply. ### 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. Contact your local sales specialist to take advantage of this service by [filling out the form on our CADI page](https://www.sigmaaldrich.com/US/en/services/custom-products/custom-milliplex-multiplex-assays-and-elisas). __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. ## [](https://www.sigmaaldrich.com)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. - [Contract ZooMAb® antibody development services](https://www.sigmaaldrich.com/US/en/services/custom-products/contract-zoomab-antibody-development-services) to generate recombinant monoclonal antibodies when existing reagents are not available or are not appropriate for your application. - Explore our [complete range of reagents and enzymes](https://www.sigmaaldrich.com/US/en/products/protein-biology/protein-sample-prep) for cell lysis and protein extraction which provides you with an array of options so that you can put together the perfect extraction protocol for your particular cells and protein. - Use [Duolink® Proximity Ligation Assays (PLA)](https://www.sigmaaldrich.com/US/en/technical-documents/technical-article/protein-biology/protein-and-nucleic-acid-interactions/duolink-pla-applications) to detect and visualize protein-protein interactions and post-translational modifications with a custom MILLIPLEX® assay or SMC® assay to quantify downstream effects. ## Request Info on Custom Services __[](https://www.sigmaaldrich.com)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](https://www.sigmaaldrich.com/US/en/technical-documents/product-supporting/smc-technologies/custom-assay-sample-testing-faqs) __For Research Use Only. Not For Use In Diagnostic Procedures.__ [Request Info on CADI Services](https://www.sigmaaldrich.com/US/en/services/custom-products/custom-milliplex-multiplex-assays-and-elisas) __Related Articles__ - [Custom Assay Development & Innovation (CADI) FAQs](https://www.sigmaaldrich.com/US/en/technical-documents/product-supporting/smc-technologies/custom-assay-sample-testing-faqs) - [Overview of Luminex® Multiplex Assay Technology | MILLIPLEX® Multiplex Assays](https://www.sigmaaldrich.com/US/en/technical-documents/product-supporting/milliplex/luminex-multiplex-assay-technology) - [An Overview of SMC® Ultrasensitive Immunoassay Technology](https://www.sigmaaldrich.com/US/en/technical-documents/product-supporting/smc-technologies/what-is-smc-technology-overview-of-ultrasensitive-immunoassay) - [How to Select Your Immunoassay Platform](https://www.sigmaaldrich.com/US/en/technical-documents/product-supporting/milliplex/how-to-select-your-immunoassay-platform) - [FemtoQuest™ Immunoassay Platform](https://www.sigmaaldrich.com/US/en/technical-documents/product-supporting/smc-technologies/femtoquest-immunoassay-platform-for-ultrasensitive-biomarker-detection) - [Belysa® Software: Monitor Immunoassay Method Reproducibility](https://www.sigmaaldrich.com/US/en/technical-documents/product-supporting/belysa-software/monitoring-immunoassay-method-reproducibility) - [Luminex® Multiplexing Platforms Comparison](https://www.sigmaaldrich.com/US/en/technical-documents/product-supporting/milliplex/luminex-multiplexing-platforms-comparison) - [Importance of Verification for High-Sensitivity Immunoassays | SMC® Technology](https://www.sigmaaldrich.com/US/en/technical-documents/product-supporting/smc-technologies/importance-of-verification-for-high-sensitivity-immunoassays) __Related Product Categories__ - [SMC® High Sensitivity Immunoassay Kits](https://www.sigmaaldrich.com/US/en/products/protein-biology/immunoassay-platform-solutions/single-molecule-counting-technology) - [MILLIPLEX® Multiplex Assays for Luminex® Instruments](https://www.sigmaaldrich.com/US/en/products/protein-biology/immunoassay-platform-solutions/milliplex-multiplex-assays-for-luminex-technology) - [Enzyme-Linked Immunosorbent Assay (ELISA) Kits](https://www.sigmaaldrich.com/US/en/products/protein-biology/immunoassay-platform-solutions/elisa-kits) - [AAW™ Automated Assay Workstation](https://www.sigmaaldrich.com/US/en/products/lab-automation/aaw-automated-assay-workstation) Top __Sign In To Continue__ To continue reading please sign in or create an account. Sign In__Don't Have An Account?__Register An unknown error has occured.