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Chiron Diagnostics' ACS:180 BR

This article was originally published in The Gray Sheet

Executive Summary

Firm gains 510(k) clearance for expanded labeling to allow marketing of the in vitro cancer antigen CA 27.29 test for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. The firm's original August 1997 clearance covers use as an aid in managing breast cancer patients with metastatic disease by monitoring progression or regression in response to treatment. Data used to support the expanded indication included 942 serial specimens from 162 patients



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