NICE recommends against Genomic Health's breast cancer diagnostic

The U.K.'s NICE published updated draft guidance recommending against use of the Oncotype DX Breast Recurrence Score to guide decisions on whether certain breast cancer patients should also have chemotherapy following surgery to remove tumors. The Oncotype DX breast cancer assay from Genomic Health Inc. (NASDAQ:GHDX) analyzes the expression of 21 genes to generate a Recurrence Score (RS) to quantify magnitude of chemotherapy benefit and likelihood of recurrence.

In 2013, the committee published guidance recommending the test to help physicians make treatment decisions in patients with estrogen receptor-positive, lymph node-negative and HER2-negative early breast cancer. NICE said NHS now uses the PREDICT tool to assess clinical risk. The committee noted that there are no data comparing Genomic Health’s test to PREDICT or “strong evidence” the test positively impacts patient outcomes. NICE also said the lack of comparative data for the diagnostic caused “uncertainty” in estimated quality-adjusted years of life (QALYs)...