Case Study: Development of AMiDot® Multiplex Autoantibody Test
We collaborated with a customer to design and develop a new generation of diagnostic tests — creating a microarray-based fluorescent immunoassay that enables simultaneous detection of multiple autoantibodies from a single patient sample. This innovative assay is now branded and marketed as AMiDot®.
The system uses a microarray printed on glass slides that are fully compatible with existing IFA (Indirect Immunofluorescence Assay) platforms. These slides can be processed alongside standard HEp-2 and tissue IFA slides on automated IFA processors, simplifying workflow integration and minimizing laboratory disruption.
Each slide is capable of testing for up to 20 distinct autoimmune antigens, providing broad diagnostic coverage within a single assay.
Throughout the project, we worked closely with our partner to design, optimize, and validate the solution — supporting every stage from research and assay development through testing, clinical validation, and manufacturing readiness.
Today, we continue to manufacture the product under contract, enabling our partner to deliver a high-quality, scalable diagnostic solution to the market.