CUSTOM ASSAY SERVICES

Singulex is proud to offer custom assays services focused upon your unique set of needs. Each custom assay project is assigned to a project manager who is accountable to you and your team. As such, our services can be as broad or narrow in scope as required. Custom assay services include the use of our GLP facility located in St. Louis, MO for testing that ranges from feasibility studies to the development of fully validated assays.

Pilot Study Sample Analysis

Evaluate your samples using our Singulex GLP testing facility and the Erenna System along with an existing validated assay. Or, once a new assay method has been developed by Singulex for the client analyte, utilize our GLP facility to test samples.

Pilot Studies Assay Development

To create or further develop an assay, quickly enhancing your biomarker performance or expand your testing menu, consider using Singulex pilot study services:

Assay Prototype Develop new assays or adapt existing client assays that need additional sensitivity. Typically, assay prototyping requires two to three weeks and may involve such tasks as managing antibody selection, developing procedures, qualifying buffers, defining calibrators, and testing spiked samples.

Assay Characterization Optimize an existing customer assay, improving KDa, sensitivity, and/or reproducibilty issues and reducing in-house development backlogs. Typically, assay characterization requires two to three weeks and involves such tasks as further improving the assay, managing issues of optimization, experimenting with protocol timing and other refinements, plus testing of plasma, serum, or other body fluid samples having known values for comparison.

Assay Validation Demonstrate that a client’s assay can be validated according to USP/ICH Guidelines with improved sensitivity and clinical utility. Typically, assay validation takes two to three weeks to perform and involves final improvements to the assay, completing remaining issues of optimization, and experimentation. Results are provided for blinded study samples in plasma, serum, or other body fluids.

To find out how Singulex custom assay services can enhance your drug discovery and development workflow, fill in the form below. (Note: all fields are required).

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