This article was originally published in The Gray Sheet
Premarket approval application is filed for the HER-2 DNA probe test kit for use to quantify the HER-2 gene in breast cancer patients, the firm announces June 18. High quantities of the gene have been associated with rapid growth of tumor cells, resistance to therapy and shorter patient survival, the firm says. Based on Vysis' Fluorescence In Situ Hybridization (FISH) technology, the kit utilizes DNA probes that bind to the HER-2 gene for direct visualization
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