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Annual Report 2011

1 in 3 or 35 million people above the age of 50 in the US choose not be screened for colorectal cancer1. This year alone, about 140,000 new cases of colorectal cancer will be diagnosed and costs of approximately $ 14 billion will be incurred to the healthcare system. Outside the US, the compliance for colorectal cancer screening is even lower. As a result, 600,000 people globally die of this disease every year2.

Clear focus on the US market

The lack of compliance to colorectal cancer screening represents a huge market opportunity for Epigenomics’ blood based colorectal cancer screening assay targeting methylated Septin9 in the United States.

In an effort to focus the activities of the company on one of the largest commercial opportunities in the molecular diagnostics industry, Epigenomics has increasingly shifted the focus of its activities for the introduction of Septin9 testing to the U.S.

With the completion of a prospective clinical validation of Epi proColon® and the initiation of the Premarket Approval (PMA) submission process to the U.S. Food and Drug Administration FDA in December 2011, the Company has taken important steps towards the potential approval of the first IVD version of the Septin9 test, Epi proColon®, in the United States.

On the commercialization side, there were further positive developments by Epigenomics and its North American laboratory partners in 2011.

  • In the first quarter 2011, Quest Diagnostics initiated a broad marketing campaign for ColoVantage™, its laboratory developed test (LDT) version of methylated Septin9
  • In March, Quest Diagnostics received New York state approval for ColoVantage™
  • In November, ARUP Laboratories presented exciting new study results for its Septin9 blood test for colorectal cancer (Septin9 LDT) at the annual meeting at Association for Molecular Pathology
  • In aggregate, more than 26.000 people in the U.S. and Canada received a Septin9 test in 2011, mainly by our partner Quest Diagnostics.

Epigenomics’ LDT partners are already creating awareness of blood-based colorectal cancer detection and thus provide an important contribution to the future launch of Epi proColon® in the U.S.A. and Canada. Current LDT partners represent potential future customers for Epigenomics once Epi proColon® gains approval by FDA.

Realignment of the marketing and sales strategy in Europe

Sales revenues from Epi proColon® in the European self-payer market have grown slower than anticipated since the market introduction of the product. Therefore, Epigenomics has revisited its marketing and sales strategy. Going forward, the company – directly and increasingly through distributors – is focusing on payers and large institutional customers with deep reach into the healthcare system in select markets in Europe and beyond. Epigenomics expects to achieve more sustainable revenues in the mid to long term after introduction of Epi proColon® 2.0 CE and the implementation of the adapted marketing strategy.

With the goal of extending the availability of Epi proColon®, during 2011 Epigenomics signed new distribution agreements with partners in Spain and South Africa.

The announcement of the positive clinical validation data for the certification of the second generation product in Europe triggered positive reactions from customers. Epi proColon® 2.0 CE was subsequently introduced into the European market and is now available through Epigenomics and its distributors.


  1. Centers for Disease Control. US Health and Data Statistics 2009.
  2. Centers for Disease Control. “Vital signs: Colorectal cancer screening, incidence, and mortality --- United States, 2002 – 2010.” MMWR Morb. Mortal. Weekly Report. 2011, 60(26):884-889