The diagnostics consultation reviews three gene expression profiling tests, MammaPrint, Oncotype DX and Mammostrat, as well as an immunohistochemistry test for the same purpose, IHC4. These tests are marketed as a guide to decision making on chemotherapy (in addition to surgery) for women with oestrogen receptor-positive, lymph node-negative, HER 2-negative early-stage breast cancer; some have been recommended in international cancer guidelines.
The document reports that NICE's Diagnostics Advisory Committee did not support the use of any of the gene expression profiling tests to decide for or against chemotherapy for breast cancer patients, due to a lack of convincing evidence of clinical effectiveness, and by extension cost effectiveness. This is despite a 2008 decision by the US Agency for Healthcare Research and Quality (AHRQ) that the Oncotype DX test did offer improved prognosis (see previous news). The committee recommended that the IHC tests, whilst promising, should for the time being only be used in research settings
The proposed recommendations are at the consultation stage, with final guidance to follow.