Industry News (Diagnostics)

FDA to Review HER-2/neu Test for Breast Cancer Recurrence

Published in Women's Health Weekly, November 13th, 1995

Oncor, Inc., Gaithersburg, Maryland, announced that the U.S. Food and Drug Administration (FDA) is preparing to review Oncor's Pre-Market Approval (PMA) Application for its investigational in vitro diagnostic genetic test system for HER-2/neu at an FDA Advisory Panel Meeting which is scheduled for November 30, 1995.

The HER-2/neu Genetic Test System is intended to aid physicians in predicting the likelihood of disease recurrence in women who have been initially diagnosed with breast cancer. Prediction, or prognosis, of breast cancer recurrence will assist physicians and patients in making better informed therapeutic decisions.

Oncor completed...

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Source: Women's Health Weekly (1995-11-13)

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