Epigenomics announced another delay to the US launch of its blood-based CRC diagnostic test Epi proColon and a moderate downgrade to its FY15 guidance. The FDA demands more evidence of increased compliance in CRC screening using Epi proColon, which is likely to necessitate a further study. With a current cash reach to H216, a cash call is likely before a possible US approval.
10 Nov 2015
New FDA demands delay US launch further
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New FDA demands delay US launch further
Epigenomics announced another delay to the US launch of its blood-based CRC diagnostic test Epi proColon and a moderate downgrade to its FY15 guidance. The FDA demands more evidence of increased compliance in CRC screening using Epi proColon, which is likely to necessitate a further study. With a current cash reach to H216, a cash call is likely before a possible US approval.