FDA panel turns down Oncor's HER-2 test
This article was originally published in Clinica
The FDA's Immunology Devices Advisory Panel voted seven to one against recommending FDA approval of Oncor's (US) HER-2 assay at its November 30th meeting. The HER-2 test utilises a fluorescent nucleic acid probe to detect over-expression of epidermal growth factor receptor in breast cancer cells. Oncor is developing the probe for use in patients with lymph node negative breast cancer as an adjunctive tool to help predict those likely to relapse.