Unleashing the Sensitivity of Single Molecule Counting (SMC™) Technology

    Ultrasensitive SMC™ technology, originally developed by Singulex®, Inc., provides an indispensable tool in the researcher’s arsenal to help them move novel biology forward, fueling the discovery and development of new therapeutics.

    Merck now offers the power of SMC™ technology to leading pharmaceutical R&D laboratories, clinical research organizations (CROs) and academic institutions around the world through the Research-Use-Only SMCxPRO™ and Erenna® immunoassay systems, immunoassay kits, reagents, and custom services. 

    SMCxPRO™ Instrument
    SMCxPRO™ Instrument with SMC™ technology quantifies low-abundance biomarkers, on the bench top.

    Previously Undetectable, Now Quantified. One Molecule at a Time.

    SMC™ Single Molecule Counting (SMC™) technology enables precise measurement of molecules at levels previously undetectable, for unprecedented biomarker insights.

    Scientists familiar with traditional immunoassays, such as ELISAs, know that sensitivity, matrix effects, and dynamic range affect how they make measurements — or if they can make them at all.

    Combining a traditional immunoassay workflow with patented SMC™ technology enables the detection of low-abundance biomarkers, such as proteins and nucleic acids, with unparalleled sensitivity and accuracy, capturing concentrations down to the femtogram/mL level. Researchers can now detect, and monitor changes in, extremely low levels of established disease biomarkers such as cardiac troponin I and cytokines.

    Sensitive. Fast. Compact.

    When the success of your research requires identifying and quantifying low-level proteins, you need technology you can rely on to detect your target.
    With the SMCxPRO™ platform you can detect extremely low-levels of established disease biomarkers, capturing concentrations down to the femtogram/mL level, and as a result monitor small changes in protein concentrations to accurately measure biomarkers associated with disease progression. In addition, the small sample volume requirements allow you to conserve valuable samples, reduce program costs and improve productivity. This affordable, fast and compact benchtop instrument allows research labs, including ones on a budget, to access reliable protein detection and expand the quest for drug discovery and development.

    SMCxPRO™ Platform Benefits

    • High sensitivity (femtogram/mL) quantification
    • Minimal bench space: 14” W x 16” H x 17.5” D
    • Affordable
    • Bead-based kits
    • Access to over 600 proven antibody pairs



    Available kits for the SMCxPRO™ Platform are continuously expanding, so check regularly for updates.

    Verified Immunoassay Kits
    DescriptionCat. No.
    SMC™ Amyloid Beta 1-40 High Sensitivity Immunoassay Kit03-0145-00
    SMC™ Amyloid Beta 1-42 High Sensitivity Immunoassay Kit03-0146-00
    SMC™ Human Cardiac
    Troponin I High Sensitivity Immunoassay Kit
    SMC™ Human Brain-Derived Neurotrophic Factor (BDNF) High Sensitivity Immunoassay Kit03-0171-00
    SMC™ Human cTNI Immunoassay Kit03-0092-00
    SMC™ Glucagon High Sensitivity Immunoassay Kit03-0153-00
    SMC™ Human IFN-γ High Sensitivity Immunoassay Kit03-0181-00
    SMC™ Human IL-1α High Sensitivity Immunoassay Kit03-0167-00
    SMC™ Human IL-1β High Sensitivity Immunoassay Kit03-0160-00
    SMC™ Human IL-1beta Immunoassay Kit03-0028-00
    SMC™ Human IL-4 High Sensitivity Immunoassay Kit03-0161-00
    SMC™ Human IL-4 Immunoassay Kit03-0052-00
    SMC™ Human IL-5 High Sensitivity Immunoassay Kit03-0168-00
    SMC™ Human IL-6 High
    Sensitivity Immunoassay Kit
    SMC™ Human IL-6 Immunoassay Kit03-0089-01
    SMC™ Human IL-10 High Sensitivity03-0176-00
    SMC™ Human IL-13 High Sensitivity Immunoassay Kit03-0156-00
    SMC™ Human IL-13v2 Immunoassay Kit03-0109-02
    SMC™ Human Interleukin 17A (IL-17A) High Sensitivity Immunoassay Kit03-0159-00
    SMC™ Human IL-17A/F Heterodimer High Sensitivity Immunoassay Kit03-0177-00
    SMC™ Human IL-17F High Sensitivity Immunoassay Kit03-0164-00
    SMC™ Human IL-22 High Sensitivity Immunoassay Kit03-0162-00
    SMC™ Human IL-22 Immunoassay Kit03-0059-01
    SMC™ Human IL-23 High Sensitivity Immunoassay Kit03-0157-00
    SMC™ Human IL-23 Immunoassay Kit03-0112-00
    SMC™ Human Thymic Stromal Lymphopoietin (TSLP) High Sensitivity Immunoassay Kit03-0172-00
    SMC™ Human TNF alpha Immunoassay Kit03-0088-00
    SMC™ Human TNFα High Sensitivity Immunoassay Kit03-0163-00
    SMC™ Human VEGF-A High Sensitivity Immunoassay Kit03-0180-00


    What is Immunogenicity?

    All biological therapeutics have the potential to induce an immune-mediated response ranging from benign to severe adverse effects. It is important to assess the immunogenicity risk of potential biotherapeutics in producing neutralizing and non-neutralizing anti-drug antibodies (ADA), especially in clinical phases of drug development. The effects of these neutralizing and non-neutralizing anti-drug antibodies can encompass diminished clinical efficacy of the biotherapeutic being administered to hypersensitivity, allergic reaction or even cytokine storms. Anti-drug antibodies induced by biologic therapeutics often impact drug pharmacokinetics, pharmacodynamics response, clinical efficacy, and patient safety.

    Immunogenicity testing on the Single Molecule Counting (SMC™) technology platform

    SMC™ technology can support all phases of immunogenicity testing using digital counting on the SMCxPRO™ high-sensitivity instrument for low-level protein detection. 
    SMC™ advantages include:
    • Ultrasensitive down to pg/mL detection for low-affinity ADA and reduced need for dilutions
    • Wide dynamic range for detection of high-affinity ADA with minimal matrix interference
    • All ADA subtypes can be detected including IgM and IgE
    • Tolerance to high drug concentrations in sample
    • Reduced wash steps for detection of low-affinity antibodies and reduced assay time
    • Integrated software package that is 21 CFR part II compliant and LIMS compatible
    SMC™ Immunogenicity Products and Services
    Our assay development kit is designed to guide and assist you with the process. Our experienced application scientists can also help design, validate and also train end-users to fully utilize the platform.
    SMC™ Immunogenicity Assay Development Kit
    (Cat. No. 03-0175-00)
    Combining our immunoassay portfolio to study the impact on the immunogenicity of a therapeutic can provide great insight into the mechanism of the response. The SMC™ technology offers increased sensitivity which may assist in the detection of low-affinity antibodies and lead to earlier detection of a primary ADA response, overcome matrix effects, and may reduce drug tolerance.

    Using the Luminex® platform, our MILLIPLEX® configurable complement and immunoglobulin panels can help you further elucidate the mechanism of response and the immune complex meditated responses to the ADA.

    Human Complement Panel 1 (Cat. No. HCMP1MAG-19K)
    Human Complement Panel 2 (Cat. No. HCMP2MAG-19K)
    Human Immunoglobulin Isotyping Panel (Cat. No. HGAMMAG-301K)
    Human IgE Single Plex Kit (Cat. No. HGAMMAG-303E)
    Mouse Immunoglobulin Isotyping Panel (Cat. No. MGAMMAG-300K)
    Mouse IgE Single Plex Kit (Cat. No. MGAMMAG-300E)

    Simple Work Flow

    Merck:/Freestyle/BI-Bioscience/Protein-Detection/singulex/Immunogenicity Page Image_700x350.png

    The benefits of ultrasensitive immunogenicity testing

    Some products are given in low/sub nM concentrations and ADA levels of 10 ng/mL can be expected to clear or neutralise all of the given drug. The extra sensitivity of the SMC™ platform can detect ADA that would otherwise be missed by traditional technologies. By having the option of increasing dilution and still detecting ADA, drug tolerance can be improved by overcoming traditional sensitivity limitations. The drug tolerance at 100 ng/mL can sometimes be poor. The SMC™ Technology allows you to detect ADA which would previously been undetectable. Low sample volumes in mouse studies or difficult to obtain human matrixes, such as spinal fluid, can be diluted for additional assays. The enhanced sensitivity of the SMC™ technology detects both IgE, present in very low concentrations, and IgM isotypes, traditionally difficult to detect.

    FDA immunogenicity guidelines

    The FDA has provided guidance for the industry which sets out recommendations to facilitate the industry’s development and validation of assays for assessment of immunogenicity. In the FDA 2019 Guidance, it is recommended that the initial screening assay be able to detect all relevant immunoglobulin (Ig) isotypes. For non-mucosal routes of administration and in the absence of a risk of anaphylaxis, the relevant ADA isotypes are IgM and IgG. For mucosal routes of administration, IgA isotype ADAs are also relevant. Also, for therapeutic protein products where there is a high risk for anaphylaxis or where anaphylaxis has been observed, results from antigen-specific IgE assays may be informative.

    It is recommended that screening and confirmatory IgG and IgM ADA assays achieve a sensitivity of at least 100 nanograms per millilitre (ng/mL), although a limit of sensitivity greater than 100 ng/mL may be acceptable depending on risk and prior knowledge. Recent data suggest that concentrations below 100 ng/mL may be associated with clinical events (Plotkin 2010; Zhou et al. 2013). Assays developed to assess IgE ADA should have sensitivity in the high picograms per millilitre (pg/mL) to low ng/mL range.