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FDA panel recommends reclassification of tumour markers

This article was originally published in Clinica

Executive Summary

The FDA's Immunology Devices Advisory Panel voted unanimously on December 1st to recommend that tumour marker assays be reclassified from Class III to Class II devices. The reclassification pertains only to assays used to monitor the recurrence of tumours or for treatment response and not those for diagnosing tumours such as prostate specific antigen assays.

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