Application Detail

Status

Closed

Description of Medical Service

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.

Description of Medical Condition

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.

Reason for Application

New MBS item

Medical Service Type

Investigative

Previous Application Number

Not Applicable

Associated Documentation

Application Form

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PICO Confirmation

Trial of non-ratified PASC Consultation Protocol for public consultationConsultation Protocol (PDF 2497 KB)
Consultation Protocol (Word 4161 KB)

Comment on the Consultation Protocol closed at 11:59 on 13 August 2014
Feedback Survey Questionaire (PDF 34 KB)
Feedback Survey Questionaire (Word 105 KB)

Assessment Report

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Public Summary Document

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Meetings for this Application

PASC

16 April 2014
14 August 2014

ESC

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MSAC

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