Oncor runs into reluctant FDA panel

WASHINGTON - An FDA advisory committee voted 7-1 with one abstention against approval of Oncor Inc.'s Inform HER-2/neu breast cancer test, which the company already is selling in eight European nations and Australia.

The Immunology Advisory Panel last week determined that ONC failed to demonstrate that Inform, the first gene-based test for predicting recurrence in breast cancer patients, was better than standard clinical procedures for predicting recurrence of tumors in node-negative patients. ...