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Vysis files for approval of breast cancer gene test:

This article was originally published in Clinica

Executive Summary

Genetic analysis firm Vysis has filed a premarket approval application with the FDA to market a test for the HER-2 breast cancer gene. In large quantities, HER-2 is associated with aggressive, difficult-to-treat cancer and a poor prognosis. Vysis test, called PathVysion, is a DNA probe kit which will be used with fluorescence in situ hybridisation, a technique in which DNA probes are labelled with a fluorescent marker which can be detected when the probe binds to the target gene. Vysis' test includes a second probe which is specific for chromosome 17, where the HER-2 gene resides. Vysis is based in Downers Grove, Illinois.

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