Epigenomics AG
Encyclopedia
Epigenomics is a molecular diagnostics company headquartered in Berlin
Berlin
Berlin is the capital city of Germany and is one of the 16 states of Germany. With a population of 3.45 million people, Berlin is Germany's largest city. It is the second most populous city proper and the seventh most populous urban area in the European Union...

, Germany with a wholly owned subsidiary, Epigenomics Inc. based in Seattle, WA.

History

Epigenomics was founded in Berlin
Berlin
Berlin is the capital city of Germany and is one of the 16 states of Germany. With a population of 3.45 million people, Berlin is Germany's largest city. It is the second most populous city proper and the seventh most populous urban area in the European Union...

, Germany in 1998. Around the same time, ORCA Biosciences was founded in Seattle, WA. The companies merged in 2000, and have focused on applying DNA methylation based biomarkers to address medical needs. Epigenomics became a publicly traded company with its listing on the Frankfurt Exchange in 2004. The company maintains a work force in Berlin, as well as in Seattle.

Focus

Epigenomics is focused on developing and marketing molecular diagnostics for oncology. The company has discovered DNA methylation
DNA methylation
DNA methylation is a biochemical process that is important for normal development in higher organisms. It involves the addition of a methyl group to the 5 position of the cytosine pyrimidine ring or the number 6 nitrogen of the adenine purine ring...

 based biomarkers for a number of oncology related indications, has developed enabling technologies for the analysis of methylation in blood and other body fluids, and is bringing medically important products to the market.

Key contributions to biomarker science based on DNA methylation include:

SEPT9
SEPT9
Septin-9 is a protein that in humans is encoded by the SEPT9 gene.-Interactions:SEPT9 has been shown to interact with SEPT2 and SEPT7.-Biology:...

 - Measurement in blood for detection of colon cancer.
SHOX2
SHOX2
Short stature homeobox 2, also known as homeobox protein Og12X or paired-related homeobox protein SHOT, is a protein that in humans is encoded by the SHOX2 gene.- Function :...

 - Measurement in lung fluid to aid in diagnosis of lung cancer.

PITX2
PITX2
Paired-like homeodomain transcription factor 2 also known as pituitary homeobox 2 is a protein that in humans is encoded by the PITX2 gene.- Function :...

 - Measurement in prostate tissue as a prognosis factor for prostate cancer.

The company continues to focus on discovering and validating DNA methylation based biomarkers, and developing the technology to make DNA methylation testing a routine practice in the clinical laboratory. Where possible, the results of these efforts are shared with the scientific community, as evidenced by >60 peer reviewed scientific publications over the past 10 years.

Products

Epigenomics has developed and launched two CE
CE
CE, Ce or ce may refer to:* Common Era , secular alternative to Anno Domini * Cerium, chemical element with symbol Ce- Titles :* Chief Executive, administrative head of some regions...

 marked IVD products based on methylation biomarkers:
  • Epi proColon - a test to measure the methylation status of the SEPT9
    SEPT9
    Septin-9 is a protein that in humans is encoded by the SEPT9 gene.-Interactions:SEPT9 has been shown to interact with SEPT2 and SEPT7.-Biology:...

     promoter in plasma as an aid in early detection of colon cancer.
  • Epi proLung - a test to measure the methylation status of the SHOX2
    SHOX2
    Short stature homeobox 2, also known as homeobox protein Og12X or paired-related homeobox protein SHOT, is a protein that in humans is encoded by the SHOX2 gene.- Function :...

     gene in bronchial lavage fluid, to help in the workup of patients suspect to have lung cancer.

These products are not currently available in the U.S.

Epigenomics has licensed the SEPT9
SEPT9
Septin-9 is a protein that in humans is encoded by the SEPT9 gene.-Interactions:SEPT9 has been shown to interact with SEPT2 and SEPT7.-Biology:...

 biomarker and certain DNA methylation technologies to Quest Diagnostics and ARUP Laboratories
ARUP Laboratories
ARUP Laboratories is a leading national reference laboratory and a nonprofit enterprise of the University of Utah and its Department of Pathology. ARUP offers more than 3,000 tests and test combinations, ranging from routine screening tests to highly esoteric molecular and genetic assays...

in the US, as well as Warnex Laboratories in Canada. These labs have independently launched Laboratory Developed Tests for the SEPT9 biomarker, and are providing this SEPT9 testing service to the medical community in the US and Canada. Although these tests were developed independently by the licensees and Epigenomics therefore cannot guarantee their performance, the results of clinical validations by these companies are very similar to those obtained by Epigenomics. Epigenomics also has a strategic partnership with Abbott Molecular for the development of an IVD test kit based on the SEPT9 biomarker. Abbott has launched this test as a CE marked IVD in Europe under the brand name mS9.
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