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NICE recommends against breast cancer diagnostics

February 4, 2012 1:14 AM UTC

The U.K.'s NICE issued draft guidance recommending against the use of three breast cancer diagnostics to guide decisions about chemotherapy use in women with estrogen receptor-positive, lymph node-negative, HER2-negative breast cancer. NICE said it could not consider the tests cost effective because evidence for their clinical efficacy is "limited." The committee noted that most studies were retrospective, which it said is associated with increased bias compared to prospective trials. The tests are MammaPrint from Agendia B.V. (Amsterdam, the Netherlands); Oncotype DX from Genomic Health Inc. (NASDAQ:GHDX); and Mammostrat from the Clarient Inc. subsidiary of General Electric Co. (NYSE:GE). MammaPrint and Oncotype use gene expression profiling, while Mammostrat is based on immunohistochemistry.

NICE said it needed more data on a fourth test -- the IHC4 immunohistochemistry test from the Royal Marsden Hospital and Queen Mary University London -- before it could recommend its widespread use. NICE said the test's incremental cost-effectiveness ratio (ICER) per quality-adjusted life year (QALY) was "dominant" compared to current practice, but the lack of data on analytical reliability and clinical utility made a recommendation for widespread use unwarranted at this time. Current practice consists of the Nottingham Prognostic Index or the Adjuvant! Online, a web-based tool to help guide treatment decisions. ...