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> Oncotype DX is the only test recommended by NICE (National Institute for Health and Clinical Excellence) in UK

4/10/2013

The NICE has published the final document (guidance) on the evaluation and recommendation of gene expression profiling and immunohistochemistry tests to guide the use of adjuvant chemotherapy in patients with newly diagnosed breast cancer.

Oncotype DX is the only test recommended by NICE (National Institute for Health and Clinical Excellence) in UK for use in clinical practice in patients with ER +, N-, HER2- when the decision to prescribe chemotherapy is unclear.

 

The NICE (National Institute for Health and Clinical Excellence) has published on September 25th (2013), the final document on the evaluation and recommendation of gene expression profiling and immunohistochemistry tests to guide the use of adjuvant chemotherapy in patients with newly diagnosed breast cancer. (Oncotype, MammaPrint, and IHC4 Mammostrat).

 

The highlights of the report include:

• Oncotype DX is the only test that is recommended to guide chemotherapy decisions in patients with breast carcinoma estrogen receptor positive (ER+), lymph node negative (LN−) and human epidermal growth factor receptor 2 negative (HER2−).

 

• The guidance also highlights that, because the evidence of the ability of the other three tests considered as part of this assessment - the IHC4, MammaPrint and Mammostrat - is currently uncertain, it has not been able to support their routine use to guide decisions about chemotherapy.

 

• NICE reports that the “highest quality evidence was reported for Oncotype DX, with data on the analytical validity, clinical validity and clinical utility of the test”.

 


• Other tests such as PAM50, UPAI-PAI1 and endopredict were even not included in the scoping exercise and therefore not assessed by NICE.

 

• The final guidance opens the use of Oncotype DX in clinical practice to UK patients.

 

NICE's full document


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