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Epigenomics AG / Key word(s): Regulatory Approval

10.03.2014 / 10:00


Epigenomics and VSA receive approval to market Epi proColon in Argentina

Berlin (Germany), Germantown, MD (U.S.A.) and Buenos Aires (Argentina) March 10, 2014 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTC: EPGNY), the German-American cancer molecular diagnostics company, and VSA ALTA COMPLEJIDAD S.A. (VSA), a leading Argentinean pharmaceutical and blood diagnostics company announced today that VSA has received approval to market the Epigenomics Epi proColon(R) kit for the blood-based detection of colorectal cancer (CRC) in Argentina.

Since 2013, Epigenomics and VSA worked together, performing extensive pre-approval work to meet the requirements of ANMAT, the diagnostic testing regulatory control body of Argentina. VSA has already secured relationships with leading diagnostic reference laboratories in the country in order to make the assay available in Argentina starting during the “Colon Cancer Awareness Month” in March. The intention of this internationally implemented campaign is to increase the awareness of colorectal cancer risks and to convince people to prevent the disease by participating in CRC screening programs. The Epi proColon(R) blood test will allow patients greater access to CRC screening in the country.

Noel Doheny, CEO of Epigenomics’ US subsidiary, commented: “We are extremely pleased about the regulatory approval to market Epi proColon(R) in Argentina. This makes Argentina the first country outside Europe to have granted approval for our test. Given VSA’s significant diagnostic testing skill set, combined with a keen focus on the colorectal cancer space, we believe VSA is an ideal partner for Epigenomics and we thank VSA for their significant efforts to achieve this regulatory milestone.”

“The Epigenomics assay enables VSA to extend its market leading efforts to improve access to colorectal cancer screening and reduce the colorectal cancer burden in Argentina,” said Luis Israel, CEO of VSA, “Due to late detection, mortality rates from colorectal cancer are still among the highest for males and females in our country, so we have made the launch and roll-out of the blood based assay a priority.”

About Epigenomics

Epigenomics (www.epigenomics.com) is a molecular diagnostics company developing and commercializing a pipeline of proprietary products for cancer. The Company’s products enable doctors to diagnose cancer earlier and more accurately, leading to improved outcomes for patients. Epigenomics’ lead product, Epi proColon(R), is a blood-based test for the early detection of colorectal cancer, which is currently marketed in Europe and is under regulatory review by the FDA for the U.S.A. Additionally, the company markets its tissue assay for use in lung cancer diagnosis, Epi proLung(R), in Europe. The Company’s technology and products have been validated through multiple partnerships with leading global diagnostic companies and testing laboratories. Epigenomics is an international company with operations in Europe and the U.S.A.

About VSA ALTA COMPLEJIDAD S.A. (VSA)

VSA (www.vsa-ac.com.ar) is an importer pharmaceutical company developing and commercializing a full range of products in medical devices and testing devices area. The Company supplies every days more than 500 products to different customer and patients, referring to ophthalmology, cardiology or dermatologic pathologies. Though his 10 years working, VSA has achieved direct relationship with key leading producer along the world, such as Lifecore LLC (USA), Aurolab (IND), Epigenomics (GER), Mani (JAP) and Aptissen (SWI). VSA ALTA COMPLEJIDAD S.A. is planning to become a leading producer of medical devices in his country, Argentina.

Contact Epigenomics AG

Antje Zeise, Manager IR | PR
Epigenomics AG
Kleine Praesidentenstrasse1
10178 Berlin
Tel +49 (0) 30 24345 386
ir@epigenomics.com
www.epigenomics.com

For US press inquiries:

Epigenomics, Inc.
20271 Goldenrod Lane, Suite 2027
Germantown, Maryland 20876
pr@epigenomics.com

Contact VSA

Mauro Alvarez, Manager.
VSA ALTA COMPLEJIDAD S.A.
Av. Mitre 3690
1605 Munro
Buenos Aires
Tel +54 11 4721 9190
malvarez@vsa-ac.com.ar
www.vsa-ac.com.ar

Epigenomics legal disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States or Canada. The analytical and clinical performance characteristics of any Epigenomics product based on this technology which may be sold at some future time in the U.S. have not been established.

End of Corporate News


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