Genomic Health recently announced that its breast cancer assay Oncotype DX™ is now available for clinical use in most states. Oncotype DX™ is a clinically validated assay that evaluates a tumor’s expression of 21 genes and quantifies the likelihood of a distant recurrence in women with node negative ER positive breast cancer.

Oncotype DX™ was prospectively validated by the National Surgical Adjuvant Breast and Bowel Project (NSABP) that involved 668 women with node negative ER-positive breast cancer treated with tamoxifen. The Recurrence Score™ is calculated from the tumor’s expression of 21 genes which include those measuring proliferation HER-2 estrogen and invasion. The scale of the score is 1-100. Patients with a score of <18 have a low risk of recurrence those with a score of 18-31 have an intermediate risk and those with a score of 31 or more have a high risk of relapse.