Epitope Diagnostics

Epitope Diagnostics, Inc. was established in 2003 and is located at San Diego, California. Since then, EDI has developed and launched many innovative ELISA and rapid test kits.
​​​​​​​In 2004, EDI was accredited by the State of California Department of Health Services, Food and Drug Branch, as a certified and licensed medical device manufacturer. Later EDI developed an innovative, odourless, and self-contained rapid test platform specifically for stool sample-based rapid tests which been patented (US 7,780,915), FDA 510(k) cleared, and CLIA-waived since 2005. This platform has gone on to be the basis of all EDI rapid test kits, including the European CE-certified OTC kit and EpiTuub iFOB test.

In 2020 Epitope introduced the fully automated random-access Chemiluminescence Analyser ECL100 and suitable high quality CLIA assays like qFOB, PE-1, Calprotectin, Helicobacter pylori, Chromogranin A and AMH. Until early 2026 this CLIA family has grown to over 70 parameters and Epitope is continuing to add assays in 2026 in the field of gastrointestinal, oncology, therapeutic drug monitoring, Alzheimer diseases and brain injury diagnosis to provide a comprehensive CLIA solution portfolio engineered for accuracy, efficiency, and clinical confidence.

In early 2025 Epitope launched the innovative unique QSE180 Autosampler, a fully automated, random-access stool sample auto-sampler and auto-extractor. Such instrument has not been available until now to the routine diagnostic. It especially aligns perfectly with our ECL100 analyser but is also an open system allowing stool sample preparation for other assays.

This game-changing technology automates everything for sample collection, significantly improving reproducibility (=standardized stool amount transfer with CV < 3%), accuracy, efficiency (= up to 180 samples / hour processing capacity) and reliability in the laboratory. By reducing human error and operational costs, it ensures more dependable results for clinicians and better outcomes for patients.