03.11.2014 | 141103_Press_release_Epigenomics_AG_Polymdeco
Berlin (Germany) and Germantown, MD (USA) – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, today announced that Polymedco, Inc., a leading provider of colorectal cancer tests in North America, reiterates its commitment to support Epi proColon® in the United States. Epi proColon® is Epigenomics’ convenient blood-based test for colorectal cancer (CRC) screening, which is under review by the U.S. Food and Drug Administration (FDA) for U.S. market approval.
Polymedco is continuing to diligently prepare for commercializing Epi proColon® once the product is approved and has started internal training measures and to establish customer and technical support. In addition, Polymedco strongly supports Epigenomics with continued logistics and personnel assistance in the upcoming ADMIT (Adherence to Minimally Invasive Testing) study, which aims to demonstrate that Epi proColon® will increase CRC participation in patients being offered this convenient blood-based test as compared to those being offered a fecal immunochemical test (FIT).
This strong support of Epigenomics’ partner is further underpinned by the commitment of Polymedco’s President and CEO, Drew Cervasio, who with a significant personal investment has meanwhile increased his ownership of Epigenomics to approximately 180,000 shares.
“As we work towards fulfilling the requirements outlined by the FDA, we are encouraged by the support and commitment displayed by Polymedco”, said Dr. Thomas Taapken, Chief Executive Officer of Epigenomics. “We are delighted with the strong signs of our strategic partners, Polymedco, and also BioChain in China, showing their belief in the future success of our product.”
During the recent months, Epigenomics worked closely with the FDA and completed the design of the ADMIT study which is now being started in the U.S. To identify appropriate patients to be enrolled, Epigenomics is conducting the study with two major U.S. health care systems, who actively manage CRC screening programs. Site initiation for the trial is now ongoing.
The ADMIT study will be conducted in average risk, screening eligible patients that have been historically non-compliant to CRC screening according to current guidelines. Once enrolled, patients will be randomized equally into two arms to be offered either the FIT stool test kit for home use or a blood draw for the Epi proColon® test. The rates of adherence in each arm will be measured and the primary objective of the study will be to show increased adherence for Epi proColon® compared to FIT testing. The study’s secondary endpoint is a measurement of compliance to colonoscopy in those patients with positive test results with Epi proColon® or FIT. The study was requested by the FDA in relation to the Company’s premarket approval (PMA) application for Epi proColon® in the U.S.
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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®, 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. and the Chinese Food and Drug Administration for China. Additionally, the Company markets its tissue assay for use in lung cancer diagnosis, Epi proLung®, 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.
Polymedco Inc. is a leading manufacturer, marketer, and distributer in the clinical laboratory marketplace. Polymedco supplies clinical diagnostic test kits and devices that are specialized in hematology and cancer. We are a world leader in non-invasive colorectal cancer screening technology, providing the new standard of care with the OC-Auto® and OC-Light® product line.
Since 1980, Polymedco has evolved into a highly skilled and successful marketing, sales, and manufacturing organization. With an experienced team of field representatives combined with strong technical service personnel, Polymedco provides a high level of customer, technical and reimbursement support.
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