Applications

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

Find out about the service or technology in this application and the medical condition it addresses. You can also view the application documents, the deadlines for providing consultation input and the outcome of the application when the MSAC process is complete.

  • Status Complete
  • Type New application
  • Pre-PASC consultation -
  • Pre-MSAC consultation -
  • Outcome -

Application details

Reason for application

New MBS item.

Service or technology in this application

The 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.

Type: Investigative

Medical condition this application addresses

Breast 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.

Meetings to consider this application

  • PASC meeting: 
    • 16 April 2014
    • 14 August 2014
  • ESC meeting: -
  • MSAC meeting: -