DGAP-News: Epigenomics AG / Key word(s): Regulatory Admission
2015-11-04 / 20:30
FDA requests further data for approval of Epigenomics’ blood based colorectal cancer screening test
Statement of CEO:
“While disappointed by the FDA’s decision, we will make every effort to address the outstanding questions as soon as possible”, said Dr. Thomas Taapken, CEO/CFO of Epigenomics AG. “We remain highly committed to providing an innovative and convenient option to those many Americans who do not undergo colorectal cancer screening. Colorectal cancer is still the second-leading cause of cancer death in the United States.”
Berlin (Germany) and Germantown, MD (U.S.A.), November 4, 2015 – Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, announces that it has received a response letter from the U.S. Food and Drug Administration (FDA) in relation to its premarket approval (PMA) application for the Company’s blood-based colorectal cancer (CRC) screening test Epi proColon(R).
In its letter, the FDA provided guidance and recommendations on how to amend the PMA to make it approvable. The agency requested additional data demonstrating that the blood-based Epi proColon(R) test will increase compliance to CRC screening in the intended use population, i.e. in those patients with a history of noncompliance to recommended CRC screening programs.
The management of Epigenomics is taking immediate steps to address the FDA’s requests. This includes a meeting with the FDA in the near-term in order to discuss how to best address the outstanding questions. It is expected that an additional study to demonstrate increased compliance and adherence of patients to blood-based CRC testing will be needed. Details of the study will be determined in dialogue with the FDA. As in the past, Epigenomics is committed to provide information about the regulatory way forward to its shareholders and to the public in a timely and comprehensive manner.
Together with its strategic commercialization partner Polymedco, Epigenomics will continue to diligently prepare for commercializing Epi proColon(R) in the United States.
In the previous ADMIT (Adherence to Minimally Invasive Testing) study, Epigenomics aimed to demonstrate that Epi proColon(R) will increase CRC participation in patients being offered this convenient blood-based test as compared to those being offered a fecal immunochemical test (FIT). While the adherence to Epi proColon(R) was nearly 100%, the participation rate to the FIT-test of 88% by far exceeded the levels seen in many studies. The FDA’s request for additional data suggests that the studied population in the ADMIT trial was not fully suitable for Epi proColon(R).
About colorectal cancer
According to the American Cancer Society, there are projected to be over 130,000 new diagnosed cases of colorectal cancer and almost 50,000 deaths from colorectal cancer in 2015. Colorectal cancer remains the second-leading cause of cancer death in the United States. Although screening and early detection of colorectal cancer can save lives, approximately 23 million Americans between the ages of 50 and 75 are not being regularly screened.
About Epi proColon(R)
Epi proColon(R) is an in-vitro PCR (polymerase chain reaction) assay for the qualitative detection of Septin9 gene methylation in DNA isolated from the patient’s plasma. Cytosine residues of the Septin9 gene are methylated in colorectal cancer tissue but not in normal colon mucosa. This tumor-specific methylation pattern can be used to detect specifically cell-free DNA shed into the blood stream by tumor cells. Detection of colorectal cancer-derived DNA in blood plasma using the Septin9 methylation biomarker has been demonstrated in multiple case control studies with colorectal cancer patients and colonoscopy-verified negative controls to be a reliable indicator of the presence of colorectal cancer.
Epigenomics is a molecular diagnostics company focused on blood-based detection of cancers using its proprietary DNA methylation biomarker technology. The Company develops and commercializes diagnostic products across multiple cancer indications with high medical need. Epigenomics’ lead product, Epi proColon(R), is a blood-based screening test for the early detection of colorectal cancer. Epi proColon(R) is currently marketed in Europe and China. For more information, visit www.epigenomics.com.
Contact Epigenomics AG
Peter Vogt, Investor & Public Relations
For U.S. press inquiries:
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.
2015-11-04 Dissemination of a Corporate News, transmitted by DGAP – a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
|Phone:||+49 30 24345-0|
|Fax:||+49 30 24345-555|
|Listed:||Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Munich, Stuttgart|
|End of News||DGAP News Service|