Epitope Diagnostics, Inc. of San Diego, CA at MEDICA 2017 in Düsseldorf -- MEDICA Trade Fair
Manufacturers

Epitope Diagnostics, Inc.

7110 Carroll Road, 92121 San Diego, CA
United States of America

Telephone +1 858 693-7877
Fax +1 858 693-7678
cs@epitopediagnostics.com

This company is co-exhibitor of
Messe Düsseldorf North America

Hall map

MEDICA 2017 hall map (Hall 3): stand C46-7

Fairground map

MEDICA 2017 fairground map: Hall 3

Our range of products

Product categories

  • 03  Diagnostics
  • 03.02  Immunochemistry (Immunology)
  • 03.02.14  Specific proteins
  • 03  Diagnostics
  • 03.02  Immunochemistry (Immunology)
  • 03.02.15  Rapid tests - Immunochemistry

Rapid tests - Immunochemistry

  • 03  Diagnostics
  • 03.02  Immunochemistry (Immunology)
  • 03.02.17  Tumor markers
  • 03  Diagnostics
  • 03.05  Infectious Immunology
  • 03.05.06  Parasitology (Infectious immunology)

Parasitology (Infectious immunology)

  • 03  Diagnostics
  • 03.05  Infectious Immunology
  • 03.05.08  Rapid tests - Infectious immunology

Rapid tests - Infectious immunology

Our products

Product category: Tumor markers

Human Pepsinogen II ELISA Kit

This ELISA (enzyme-linked immunosorbent assay) kit is intended for the quantitative measurement of human pepsinogen II levels in serum. Determination of human serum pepsinogen I/II ratio has been reported to be a useful tool in aiding the diagnosis of the functional states of acid-secreting gastric muscosa.

This pepsinogen II ELISA kit is for in-vitro diagnostic use.

Background

Pepsinogen consists of a single polypeptide chain of 375 amino acid residues with an average molecular weight of 42 kDa. Pepsinogen I is synthesized at gastric cheif cells and mucous neck cells, while pepsinogen II is also produced by clear mucous cells of antrum, etc. The clinical applications of measuring pepsinogen I and II are a useful aid in the diagnosis of severe atrophic gastritis and stomach cancer. It has been suggested that the measurement of serum pepsinogens serve as a "serological biopsy" for predicting the presence of atrophic gastritis or superficial gastritis.

Atrophic Gastritis: It has been found the serum pepsinogen I levels falling lower than 20 ng/ml was highly specific for severe atrophic gastritis. It was also observed that serum pepsinogen I levels fell with increasing severity of mucosal damage in such cases. The diagnostic sensitivity and specificity of serum pepsinogen I levels for advanced atrophic corpus gastritis are about 92% and 90% respectively. On the other hand, the decrease in serum pepsinogen I levels in patients with pernicious anemia and atrophic gastritis was found to be associated with normal or raised pepsinogen II levels. Therefore, a pepsinogen I/pepsinogen II ratio is significantly lower than those with superficial gastritis or normal remnant mucosa.

Stomach Cancer: Low serum pepsinogen I levels were found in patients with gastric cancer, with a threefold higher incidence. Other studies have concluded that low serum pepsinogen I levels may identify persons at increased risk for intestinal types of stomach cancer.

Duodenal Ulcers: A low serum pepsinogen I level can exclude a diagnosis of duodenal ulcer. Although a high pepsinogen I level has less clinical use for establishing this diagnosis, the combination of hypergastinemia and a highly evelated serum pepsinogen I level strongly suggests the possibility of Zollinger-Ellison syndrome.

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Product category: Rapid tests - Immunochemistry, Rapid tests - Infectious immunology

Human Anti-Gliadin IgA ELISA Kit

This ELISA (enzyme-linked immunosorbent assay) kit is intended for the quantitative detection of human anti-gliadin IgA levels in serum. This assay is a useful tool in the aid of diagnosis of celiac disease.

This ELISA kit is for in-vitro diagnostic use.

Background

Celiac disease, or gluten-sensitive enteropathy, is characterized by atrophy of the small intestinal villi, leading to so-called 'flat mucosa' occurring in both adults and children. It is caused by a pathological intolerance to gliadin, resulting in inflammation and atrophy of the small intestine mucosa. Clinical manifestations include malabsorption with symptoms of diarrhea, steatorrhea, and nutritional/vitamin deficiencies. Secondary immunologic illnesses, such as atopic dermatitis, dermatitis herpetiformis, alopecia, and aphthous ulcers may be the primary presentation.

As celiac disease is caused by the uptake of gluten, consequently a gluten-free diet cures the disease completely and thus has to be maintained for life. Renewed consumption of gliadin leads to a recurrence of the disease symptoms. The disease is HLA-associated and manifests at any age. A high incidence range up to 1:300 was found in European countries and approximately 1:250 in the United States.

Clinical diagnosis of celiac disease is made by small intestinal biopsy and supported by serological markers. Human antibodies against gliadin and tissue Transglutaminase (tTG) are major serological markers. Circulating IgG and IgA antibodies to gliadin are found in the serum of most but not all celiac disease patients. Both IgG and IgA antibodies are detected in sera of patients with gluten-sensitive enteropathy.

It has been reported that IgA antibodies are less sensitive but more specfic a marker of the disease and its measurement is useful in the following disease activity and monitoring maintenance of a gluten-free diet. IgG antibodies appear to be more sensitive but less specific markers than IgA. It is recommended that both antibodies should be measured due to the high incidence of IgA deficiency among celiac patients, which may mask the disease. Antibodies testing is also important in detecting individuals who are at risk for having celiac disease but do not show symptoms, individuals with atypical symptoms or exstra-intestinal manifestations of celiac disease, and in individuals with presumed celiac disease who fail to respond to a gluten-free diet.

Patients with positive antibodies tests must undergo small intestine biopsies to confirm the diagnosis and assess the degree of mucosal involvement. Antibodies against gliadin may be the only serological marker in neonates, as anti-tTG and EMA auto-antibodies are not present at this age. Consequently anti-gliadin antibodies are the earliest serological marker for pediatricians when diagnosing celiac disease.

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Product category: Specific proteins

Anti-Auristatin Monoclonal Antibodies

This anti-MMAE monoclonal antibody is designed for use in an ELISA environment. It is the primary antibody used in the Epitope Diagnostics Intact MMAE Antibody-Drug Conjugate ELISA Kit.

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About us

Company details

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.

History
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 kit, including the European CE certified OTC kit, EpiTuub iFOB test.

ISO Certification
EDI is an ISO 13485:2003 certified company. 

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