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Immunomedics' CEA assay data to be re-analysed

This article was originally published in Clinica

Executive Summary

Although Immunomedics had hoped for a recommendation for approval for its colorectal imaging agent, CEA-Scan (arcitumomab) assay, on October 17th, the company appreciates that the US FDA oncologic drugs advisory panel "was not necessarily the correct advisory group to evaluate a diagnostic imaging agent". The panel requested that review of the agent be reassigned to a medical imaging devices advisory committee (see Clinica No 677, p 15).

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