1473 - A 50 gene signature assay for predicting breast cancer recurrence

Page last updated: 12 November 2021

Application Detail

Description of Medical Service

The assay provides a 50 gene profile that is used to assess the prognosis and predict response to treatment of breast cancer patients. The Risk of Recurrence (ROR) score is based on the identification of the four intrinsic breast cancer subtypes, Luminal A, Luminal B, HER2-enriched, and Basal-like. The unique genetic profile is produced using a diagnostic kit which quantifies mRNA expression and can be performed in local laboratories provided they have the NanoString nCounter® Dx technology (Prosigna enabled).

Description of Medical Condition

Prosigna® is a 50-gene test that is designed to identify intrinsic breast cancer subtypes and to generate a Risk of Recurrence (ROR) score. This is then used to tailor the most appropriate therapy for that type of primary breast cancer. It will be used for women with HER2 –ve, ER and/or PR +ve breast cancer who do not have clear cut treatment choices.

Reason for Application

New Application

Medical Service Type


Previous Application Number

Not Applicable

Associated Documentation

Application Form

Application Form (PDF 428 KB)
Application Form (Word 175 KB)

Consultation Survey

Consultation Survey (PDF 97 KB)
Consultation Survey (Word 508 KB)

PICO Confirmation


Assessment Report


Public Summary Document

Public Summary Document - November 2017(PDF 352 KB)
Public Summary Document - November 2017 (Word 136 KB)

Public Summary Document - July 2021 (PDF 270 KB)
Public Summary Document - July 2021 (Word 72 KB)

Meetings for this Application


12 April 2017


5 October 2017


23 November 2017
29-30 July 2021

Stakeholder Meeting

The Royal College of Pathologists of Australasia (RCPA), together with the Department of Health and Cancer Australia, hosted a workshop on 21 June 2021 to discuss options for publicly funded access to gene expression profiling (GEP) tests in Australia. Participants also included representatives from consumer organisations, clinicians with experience and expertise in breast cancer, pathology and clinical genetics, and representatives of the four current GEP test providers (Endopredict®, MammaPrint®, Oncotype DX®, Prosigna®). The outcome of this workshop was that GEP test providers were invited to lodge focussed applications to support the prognostic value of GEP tests; the focussed application should also address Therapeutic Goods Administration (TGA) registration, the Department’s proposed Medicare Benefits Schedule (MBS) item fee consistent with prognostic value, and provide a proposed MBS item descriptor. Focussed applications were received for EndoPredict from Myriad Genetics Pty Ltd, MammaPrint from Genome Investigation Pty Ltd and Prosigna from Veracyte, Inc.

As part of the appraisal process for these focussed applications, the Department also invited input from a range of stakeholders through public consultation, primarily facilitated by workshop participants. Individuals or organisations with an interest in this application, including lived experience of the health conditions and/or treatment that the application is addressing, were able to provide input by the deadline of 12 July 2021.

Focussed applications and public consultation feedback were considered by the Medical Services Advisory Committee (MSAC) at its 29-30 July 2021 meeting. The MSAC Minutes for the GEP test applications are published above.