Epitope Diagnostics Inc. joins MetroConnect to expand international growth


SAN DIEGO – Epitope Diagnostics Inc.is pleased to announce it has been selected to take part in MetroConnect 2018, an export assistance program run by the World Trade Center San Diego (WTC) and designed to help San Diego companies accelerate their global growth.

This program will allow Epitope Diagnostics to have further spending on R&D in order to stay competitive in the IVD market by manufacturing niche products that call for extremely expensive reagents for development.  This program will also help Epitope’s exhibition costs that will in turn benefit healthcare in regions and territories where our products are not established.

 “With this opportunity, an increase in exports will allow Epitope to promote the San Diego community while fostering business and exportation partnerships.” – Stefanie Dallozette – Business Operations Manager

As the flagship export assistance program of World Trade Center San Diego, MetroConnect helps to cultivate a pipeline of export-ready firms to elevate San Diego’s global reach. Now in its fourth program-year, company participants will receive a $10,000 grant, presented by JPMorgan Chase & Co., and a suite of programmatic support services to assist with international expansion strategies. Local companies,  Epitope Diagnostics included, will have access to a dedicated staff manager at WTC, and will receive guidance on export compliance, financing and fundraising, among other international support services.

 “We applaud Epitope Diagnostics Inc. for taking the next step in going global,” said Nikia Clarke, executive director of World Trade Center San Diego. “With SMEs like this at the forefront, San Diego must continue to increase its export capacity and boost the region’s global identity. MetroConnect is equipping these companies with the resources necessary to do just that.”

The MetroConnect program is highly competitive, with just 20 companies selected based on a variety of criteria including market interest, assessed impact of funds, current international traction and more. Applicants were assessed by a panel of judges, including representatives from Qualcomm Ventures, Biocom, U.S. Commercial Service, Rough Draft Brewing, San Diego State University,  UC San Diego, San Diego Regional EDC and WTC San Diego.

Epitope Diagnostics Inc. joins a cohort of 19 other companies representing a unique cross-section of San Diego’s industries, from defense to life sciences to software and craft goods – each with plans to take San Diego innovation globally. Collectively, the cohort employs 1,181 and has a combined revenue of $392 million revenue and $115 million in international revenue.

Participating companies will also be considered for the program’s MetroConnect Grand Prize Pitchfest in June 2019, which will provide an additional $35,000 to help one or two companies further advance their global agendas. Past grand prize winners include Cypher Genomics (now part of Human Longevity, Inc.), Rough Draft Brewing and CureMatch.

MetroConnect is underwritten by JPMorgan Chase & Co., with additional support provided by Air Canada, Japan Airlines, Japan External Trade Organization, Qualcomm, SYSTRAN, Taylor Guitars, Lufthansa, City of San Diego and others.

The announcement was made by Mayor Kevin L. Faulconer and WTC San Diego on September 26 at WeWork.

New Anti-Müllerian Hormone ELISA Kit Launched

Anti-Müllerian hormone (AMH) is uniquely produced by granulosa cells of ovarian follicles during folliculogenesis. It is currently the best measure of ovarian reserve in the clinical setting and may also be used to predict ovarian response in IVF and to monitor patients with a history of granulosa cell tumors.


Epitope Diagnostics is proud to present a robust AMH ELISA kit with the following specifications:


This kit is currently available for research use in the United States (KTR-804) and for IVD use (KT-804) internationally.

Study Spotlight: Chromogranin A as a Potential Prognostic Marker for CRPC Patients


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, click here.


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 Launches a Novel 25-OH Vitamin D ELISA Kit

San Diego, CA, May 11, 2015 --(PR.com)-- According to data from the National Health and Nutrition Examination Survey, from 2001 to 2006, about one quarter of the U.S. population had inadequate levels of vitamin D and about 8% were at risk for vitamin D insufficiency.

Epitope Diagnostics, Inc. has launched a novel CE marked ELISA kit to measure total 25-Hydroxy Vitamin D2 and D3.

Vitamin D is a compound that is essential to the human body. Insufficiency and deficiency increases the risk of bone fractures and debilitating bone related disease, such as osteoporosis.

Vitamin D comes in many forms such as D2 (ergocalciferol) and D3 (cholecaliferol). Their hydroxylated forms, 25-OH vitamin D2 and 25-OH vitamin D3 (calcifidiol) are the biologically active forms. The function of these molecules to help regulate the uptake of calcium in the gut in order to maintain a healthy skeletal system.

Insufficient vitamin D levels correspond to low levels of calcium and increase bone related health risks. An overdose of vitamin D, which may come from taking too many supplements, can lead to vitamin D toxicity and even death. The importance of measuring this molecule cannot be overstated.

Epitope Diagnostics’ Total 25-OH Vitamin D ELISA kit is a robust 2-hour assay that reliably measures both forms of active vitamin D in serum or EDTA-plasma samples.

In current vitamin D assays, blood samples must be prepared and processed to release vitamin from its bound form before it can be measured with an assay. The Epitope Diagnostics Total 25-OH Vitamin D ELISA kit is unique in that a special buffer has been included to separate vitamin D from its binding protein in the assay well so no extra sample processing steps are required.

In addition, this kit has been streamlined to be user friendly and time efficient. It features a set of liquid standards and controls, ready-to-use liquid tracer, and liquid biotinylated vitamin D analog. It has a high analytical sensitivity of 0.96 ng/ml with the highest calibrator being 150 ng/ml.

“Vitamin D deficiency is a serious problem, especially now when so many people in our community don’t get enough of it. On the other hand, it’s easy to get supplements at variable doses over the counter these days so vitamin D overdose is also a concern,” said Ping Gao, President and CEO. “We’re proud to present this kit as part of the solution.”

Website Relaunch

Our new website has arrived!

This was a major update from our old site, which was beginning to deteriorate without a dedicated webmaster so we're happy to have a brand new, up-to-date version 2.0 release. Currently, the only the product list is available for viewing, but we are slowly rolling out individual product pages over the next few weeks. Please be patient, as many improvements are happening behind the scenes.

As always, if you see any broken links, or have any questions, please let us know through the contact page.


EDI launches new anti-auristatin monoclonal antibodies and ELISA kits

Epitope Diagnostics is proud to announce that a new set of monoclonal antibodies specific to auristatins is now commercially available. The novel clones are specific against detecting monomethyl auristatin E (MMAE) and monomethyl auristatin F (MMAF), two anti-cancer compounds. Using these new monoclonal antibodies, we were able to successfully develop highly sensitive MMAE-ADC and MMAF-ADC ELISA kits.

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