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Vysis seeks European approval for breast cancer gene test

This article was originally published in Clinica

Executive Summary

Vysis has taken the first step in its bid to market its test for the HER-2 breast cancer gene in Europe. The company has filed an application to register the test with the Agence du Medicament in France, which unlike most of the other European authorities, requires premarket approval for such tests. Once approved in France, the company says it will be able to market it in most of the other European countries without further approval.

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