Epitope Diagnostics Inc. (EDI) strives to develop, manufacture, and market the highest quality and most innovative in-vitro diagnostics (IVD) products to the global research, pharmaceutical, and healthcare community. We seek to become a major contributor in resolving the unmet medical needs of the world.


Located in America's finest city and one of the biotech hubs of the U.S., Epitope Diagnostics, Inc. was established in 2003. Since then, EDI has developed and launched many innovative ELISA and rapid test kits that meet the needs of healthcare communities worldwide. For instance, EDI launched the world's first commercial test for the determination of alpha-1-HS-glycoprotein, the human fetuin-A ELISA kit. Many clinical studies were performed using this test which led to the publication of more than 20 scientific papers.

​​​​​​​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. A year later, EDI developed and innovative, odorless, and self-contained rapid test platform specifically for stool sample-based rapid tests. This innovative device has 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 our rapid test kits, including the European CE-certified OTC kit and EpiTuub iFOB test.


May 2003

EDI was founded

February 2004

The first human Fetuin A ELISA Kit

January 2010

Active and Total GLP-1 ELISA Kits

January 2010

Human Chromogranin A ELISA Kit

June 2013

Specific Antibodies and ELISA kits to DM1, MMAE, and MMAF

December 2010

Launched the first HAHA ELISA kit

August 2010

US Patent for Fecal Sample Test Device

December 2013

Launched the first human Intact FGF-21 ELISA Kit

July 2015

Herceptin ELISA

October 2020

ECL100 and qFOB PE-1, Calprotectin, H. Pylori, CgA , AMH

July 2022