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This article was originally published in The Gray Sheet
Oncor HER-2/neu genetic test system: Premarket approval application for the in vitro diagnostic test, used as an aid "in predicting the likelihood of disease recurrence in women initially diagnosed with breast cancer," is slated for review by FDA's Immunology Devices Panel Nov. 30, the Gaithersburg, Maryland firm announces. Oncor filed its PMA with FDA in February 1994...
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