WKN: A1K051 ISIN: DE000A1K0516 Typ: Aktie
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Ad hoc: Epigenomics AG Announces FDA Advisory Committee Meeting to Review Epi proColon®
27.11.2013
Berlin, Germany – Epigenomics AG (ISIN: DE000A1K0516) announces that the Company was informed by the U.S. Food and Drug Administration (FDA) via the premarket approval (PMA) review process for Epi proColon® that the Meeting of the Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee has been tentatively scheduled for Tuesday, March 25th, 2014. Epigenomics expects the final date for the meeting will be announced publicly via a Federal Register notification. Epi proColon® is Epigenomics’ blood-based screening test for colorectal cancer.
The Company had completed filing a PMA submission in early 2013, which was subsequently accepted for review and granted priority review status by the FDA in February 2013.
After the Company has completed all outstanding questions and information requests by the FDA, this represents an important step forward towards market introduction of Epi proColon® in the USA.
- End of Ad hoc – |
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