Epitope Diagnostics, Inc.

San Diego,  CA 
United States
  • Booth: 1575

Booth Profile

Epitope Diagnostics Inc. (EDI) strives to develop, manufacture, and market the highest quality and most innovated 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.

 Press Releases

  • San Diego, CA  – Epitope Diagnostics is proud to introduce a new adrenocortocotropic hormone (ACTH) ELISA Kit, which measures ACTH levels with high sensitivity and robust assay performance characteristics.

    The ELISA (enzyme-linked immunosorbent assay) platform is a popular method for accurate detection of various molecules. It is relatively easy to perform, inexpensive, and does not require specialized equipment, making it easy to perform in clinical laboratories of all sizes. One drawback, however, is that current ACTH ELISA kits on the market are 4-hour tests. Long incubation periods decrease the efficiency of the laboratory and occupy space in automated ELISA systems.

    Epitope Diagnostics has put great effort into the development of a simplified, robust, 2-hour ACTH assay with a high analytical sensitivity (LLOD: 0.4 pg/mL) and dynamic range. The assay procedure essentially remains unchanged except for the shorter incubation period, making this an easy transition for laboratory staff.

    ACTH levels outside the normal range is associated with of many different diseases, such as Addison’s disease, congenital adrenal hyperplasia, Cushing’s syndrome, multiple endocrine neoplasia type I, and hypopituitarism, thereby making it an important marker in the research and diagnosis of these diseases.

    About Epitope Diagnostics, Inc.

    Established since 2003, Epitope Diagnostics, Inc. is an ISO 13845 certified medical device manufacturing company located in the Sorrento Valley biotech hub of San Diego, California. They specialize in development and manufacture of products for the global medical device and diagnostics industry. Their areas of interest include gastrointestinal, cardiovascular, infectious and autoimmune disease, as well as tumors/cancers and calcium/bone metabolism.

  • Epitope Diagnostics’ EDI Human Chromogranin A ELISA Kit was recently used by a research group lead by Dr. Ugo De Giorgi to publish two key papers highlighting another aspect of the relationship between chromogranin A (CgA) and prostate cancer.

    The two papers, published by Conteduca et al and Burgio et al, examined patients with castration-resistant prostate cancer (CRPC) who had received previous docetaxel chemotherapy treatment. Using the range established by the EDI Chromogranin A ELISA Kit, the patients were divided into three groups based on baseline CgA levels: normal CgA (<120 ug/ml), under 3 time normal (<360 ug/ml), and above 3 time normal (>360 ug/ml).

    Prostate specific antigen was then monitored as the patients received antiandrogen treatment, either with abiraterone or enzalutamide, in order to track the progression free survival.

    In the group treated with abiraterone, a statistically significant difference was discovered between the median progression free survival rate of those with normal CgA (group A), under 3 times normal CgA (group B), and above 3 times normal CgA (group C). Similarly, there was also a statistically significant difference in PFS among the three CgA groups in patients treated with enzalutamide.

    These results showed that serum CgA may act as a practical predictor of disease prognosis in patients with CRPC upon treatment with abiraterone or enzalutamide. While these studies were small, the results are encouraging of further expanded study of the relationship between CgA and prostate cancer.

    CgA is a 439 kDa glycoprotein. The circulating molecular form of CgA is heterogeneous. Common CgA assays employ antibodies with variable CgA-specific epitopes, leading to the detection of different CgA molecules, as well as different cut-offs for normal range. The molecular form related to prostate cancer is not well known. We are pleased to see the consistent clinical results yielded by the EDI Chromogranin A ELISA Kit in this study. It is encouraging to see that this kit may have a potential role in future clinical management of CRPC patient, leading to better monitoring and possibly improved survival rate.

    Epitope Diagnostics is committed to producing high quality diagnostic kits that may aid in making new discoveries and supporting human health. We are happy that our chromogranin A kit played a role in the establishment of these results.  

    For more information regarding all our chromogranin A kit options, visit our website at www.epitopediagnostics.com.  


    Burgio SL, Conteduca V, Menna C, Carretta E, Rossi L, Bianchi E, Kopf B, Fabbri F, Amadori D, & De Giorgi U. 2014. Chromogranin A predicts outcome in prostate cancer tatients treated with abiraterone. Society for Endocrinology. 21:3. 487-493. (doi:10.1530/ERC-14-0071)

    Conteduca V, Burgio SL, Menna C, Carretta E, Rossi L, Biachi E, Masini C, Amadori D, & De Giorgi U. 2014. Chromogranin A is a Potential Prognostic Marker in Prostate Cancer Patients treated with Enzalutamide. The Prostate. 74:1691-1696. (doi:10.1002/pros.22890)

  • Epitope Diagnostics, Inc. (EDI), is pleased to announce it has received certification for the Vitamin D Standardization Program (VDSP) for vitamin D measurement in the EDI™ Total 25-OH Vitamin D EIA Kit. CDC’s Vitamin D Standardization-Certification Program (VDSCP) evaluates the accuracy and reliability of vitamin D tests using well-established procedures, and certifies those that have a certain accuracy and precision.

    The National Institutes of Health (NIH) Office of Dietary Supplements (ODS) established the Vitamin D Standardization Program (VDSP) in November 2010. Part of the ODS Vitamin D Initiative, VDSP is an international collaborative effort to standardize the laboratory measurement of vitamin D status.

    The role of Vitamin D in regulating circulating levels of Calcium and Phosphorous to ensure normal bone mineralization is well known.  Emerging evidence correlates insufficient levels of Vitamin D to an increased risk of developing non skeletal pathologies such as cardiovascular disease, cancer, diabetes, autoimmune diseases and infectious diseases. EDI’s VDSP certification confirms the quality and reliability in the EDI™ Total 25-OH Vitamin D EIA Kit. 

    Continuing EDI’s expertise in endocrinology and Vitamin D testing, EDI will soon launch a fully automated chemiluminescence analyzer with validated assays to enable clinicians to generate reproducible results, enhance accuracy and reliability, and to deliver innovative solutions for diagnostics, therapy monitoring and research.

 Additional Info

Included in the Export Interest Directory?
Business Needs:
Direct Sales, Distributor/Agent/Representative
Products to be exported:
Immunoassays, lateral flow tests, Chemiluminescence Systems
Countries of Interest:
Belize, Christmas Island, Guam, Iceland, Indonesia, Jordan, Lithuania, Morocco, Oman, Pakistan, Panama, Peru, Philippines, Qatar, Venezuela, Vietnam