FDA
25th March 2014

Meeting Materials NOW Available! – Epipro Colon & Cologuard

March 26-27, 2014: Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Meeting.

Meeting Materials NOW Available! – Epipro Colon & Cologuard

March 26-27, 2014: Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee Meeting 

Location:

Hilton Washington DC North/Gaithersburg – Salons A, B, C, and D

620 Perry Pwky.

Gaithersburg, MD 20877

Please click HERE to access the FDA meeting materials associated with this meeting. In the meeting materials, you will find the original meeting announcement, the agenda, committee roster(s), webcast information, FDA proposed questions and other relevant briefing information.

You can access the current roster of the Molecular and Clinical Genetics Advisory Committee HERE.

On the first day (March 26th, 2014) of this two-day meeting, the committee will discuss, make recommendations and vote on information related to the premarket approval application sponsored by Epigenomics, Inc. for the Epi proColon. The Epi proColon test is a qualitative in vitro diagnostic method for the detection of methylated Septin 9 DNA in plasma derived from patient whole blood specimens. Methylation of the target Septin 9 DNA sequence has been associated with the occurrence of colorectal cancer (CRC). The test is indicated to screen patients for CRC who are defined as average risk for CRC by current screening guidelines. The Epi proColon test is not intended to replace colorectal screening by colonoscopy. Patients with a positive Epi proColon test result should be referred for diagnostic colonoscopy. The Epi proColon test results are intended to be used in conjunction with the physician’s assessment of history, other risk factors, and professional guidelines.

On the second day of the meeting (March 27th, 2014) the committee will discuss, make recommendations and vote on information related to the premarket approval application for the Cologuard device, sponsored by Exact Sciences. Cologuard is an in vitro diagnostic device designed to analyze patients’ stool for detection of hemoglobin, multiple DNA methylation and mutational markers, and the total amount of human DNA. Cologuard is intended for use as an adjunctive screening test for the detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. A positive result may indicate the presence of colorectal cancer or premalignant colorectal neoplasia. Cologuard is not intended as a replacement for colonoscopy. Cologuard is intended to be used in conjunction with colonoscopy and other test methods in accordance with recognized screening guidelines.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

Do you want to find out what happens during this device’s FDA AdComm meeting? Great news – ISS can help you! Click on the link below in order to receive a summary of this meeting’s outcome! 

Drug AdComm Follow-up Request

 

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