Has the Oncotype DX assay been approved for use in the U.S.?
Research and validation studies have already been performed on the 21-Gene Oncotype DX Breast Cancer Assay for the following indications: N-, ER+; Single Gene Reporting of ER/PR; N+. The Oncotype DX assay for these indications is currently commercially available. The Oncotype DX assay was developed and its performance characteristics were determined by Genomic Health, Inc. The laboratory is regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high-complexity clinical testing. The Oncotype DX assay is used for clinical purposes, and it should not be regarded as investigational or for research. Oncotype DX assay results are adjunctive to the ordering physician’s workup.
