Australian Government - Department of Health

Medical Services Advisory Committee (MSAC)

1376 - MammaPrint® 70-gene microarray mRNA gene expression profile breast cancer signature to quantify the risk of disease recurrence and predict adjuvant chemotherapy benefit.

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Application Number1376
Application NameMammaPrint® 70-gene microarray mRNA gene expression profile breast cancer signature to quantify the risk of disease recurrence and predict adjuvant chemotherapy benefit.
Description of Medical ServiceThe primary aim of MammaPrint is to ascertain the risk of recurrence of early breast cancer. The service generates a binary result which can help determine whether or not a patient requires chemotherapy and ensure that the right treatment is given to the right patient. The risk score generated is established through a comparison of 70 scientifically selected genes which have established links to the seven stages of metastasis. The process involves sending a small cancer tissue sample to the Agendia Californian laboratory in the USA, which then processes and issues a result, within 10 working days. In multiple overseas studies, this 70-gene signature has now been shown to be both validated and cost-effective such that it is now deemed to be an important investigation for women with early breast cancer.     
Description of Medical ConditionBreast cancer is the second most frequently diagnosed cancer in women. It is the most common cause of cancer death in women in Australia today, affecting 1 in 10 Australian women. This illness is widely accepted as being a heterogeneous group of diseases caused by a range of different mutations occurring in differing frequencies. Over 34 specific breast cancer driver mutations are currently known to be specifically causal in this disease, often with several mutations acting simultaneously within one tumour. With such a diverse range of mutations involved, cancer outcomes are variable. Metastatic breast cancer occurs in 7 distinct steps, and each breast cancer has a unique genetic makeup directly linking to cancer growth at each stage. MammaPrint, the 70-gene signature, assesses via microarray mRNA analysis, the number of genes that affect these distinct steps, and has been validated internationally to predict the risk of recurrence of breast cancer.
Consultation ProtocolTrial of non-ratified PASC Consultation Protocol for public consultation
Consultation Protocol (PDF 2497 KB)
Consultation Protocol (Word 4161 KB)

Your feedback is requested by 13 August 2014 to enable the collation of responses to be given to PASC. Please find the relevant questionnaire below.
Feedback Survey Questionaire (PDF 34 KB)
Feedback Survey Questionaire (Word 105 KB)
Final Protocol-
Reports-
MSAC Outcomes-

Meetings for this Application

Meeting Type:Date:
PASC16-17 April 2014
14-15 August 2014
ESC -
MSAC -

Page currency, Latest update: 26 November, 2014