NEW YORK (GenomeWeb) – EpiGenomics said on Monday that it has received a "not approvable letter" from the US Food and Drug Administration for its Epi proColon screening test for colorectal cancer.

According to the Berlin, Germany-based molecular diagnostics firm, "the FDA determined that while the studies performed so far have established the clinical performance characteristics of the test, the [Premarket Approval] application does not yet contain sufficient evidence to warrant an approval for Epi proColon."

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This year's Breakthrough Prize winners include a pair that developed a therapy for spinal muscular atrophy.

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Oct
23
Sponsored by
PerkinElmer

This webinar will address a range of methods for optimizing small RNA library preparation.

Nov
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Sponsored by
Sophia Genetics

With the Next Generation Sequencing (NGS), genomes sequencing has been democratized over the last decades with the detection of genomic alterations, thus replacing Sanger sequencing.

Nov
29
Sponsored by
Schott

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