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UK's NICE Recommends Use of Genomic Health's OncoType DX in Draft Guidance

NEW YORK (GenomeWeb News) – The UK's National Institute for Health and Clinical Evidence yesterday issued a draft guidance recommending the use of Genomic Health's OncoType DX in certain early-stage breast cancer patients to help guide chemotherapy decisions.

OncoType DX was one of four tests available to the UK's National Health Service that were evaluated. The other three tests included Agendia's MammaPrint, Clarient's Mammostrat, and an IHC4 test developed by a British academic research group, none of which received the same recommendation as OncoType DX.

The NICE draft guidance recommended use of OncoType DX for patients with estrogen receptor-positive (ER+), lymph node-negative (LN-) and human epidermal growth factor receptor 2 negative (HER2-) early breast cancer to help guide chemotherapy decisions if the patient as assessed as being at intermediate risk; where the decision to prescribe chemotherapy remains unclear and OncoType is likely to help predict the course of the disease; and if the manufacturer provides the test to NHS organizations at a price agreed to through a confidential agreement with NICE.

NICE noted in the draft guidance that Genomic Health had made a proposal to provide OncoType DX at a "revised price" from the £2,580 ($3,979) that was used in the original economic analysis, but the revised price has not been disclosed.

NICE also encouraged the collection of further data on the use of OncoType DX by the NHS. It said that "clinical utility of the test is warranted, including robust evidence on the impact of Oncotype DX on clinical decision-making in England … and the ability of the test to predict the benefit of chemotherapy."

While OncoType DX received a recommendation in the draft guidance, the Mammaprint, Mammostrat, and IHC4 tests were recommended only for research in people with ER+, LN-, and HER2- early breast cancer to provide evidence about clinical outcomes and determine if the tests can predict the benefit of chemotherapy. "The tests are not recommended for general use in these people because of uncertainty about their overall clinical benefit and consequently their cost-effectiveness," NICE said in the guidance document.

The views expressed in the draft guidance reflect those of NICE's Diagnostics Advisory Committee. NICE said that it is accepting comments from registered stakeholders, healthcare professionals, and the public on the recommendations and the review detailed in the document. The consultation on the draft guidance closes on March 11, 2013.

The Committee plans to meet again at a later date to consider the evidence, the draft guidance, and comments before making its final recommendations.

William Quirk, an analyst with investment bank Piper Jaffray, estimated in a note published today that the early-stage breast cancer test market represents a $48 million annual opportunity for Genomic Health.