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Vysis seeks Herceptin claim for HER-2 test in US

This article was originally published in Clinica

Executive Summary

Vysis has submitted a PMA supplement to the FDA for permission to market its gene-based test as a means for selecting breast cancer patients who are more likely to respond to therapy with the monoclonal, antibody-based drug, Herceptin. The Downers Grove, Illinois company filed the supplement jointly with Genentech, Herceptin's manufacturer and US distributor.





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