Applications

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

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 Not supported

Application details

Reason for application

New application.

Service or technology in this application

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).

Type: Therapeutic

Medical condition this application addresses

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.

Application documents

Application form

Consultation survey

Public summary document – November 2017

Public summary document – July 2021

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Meetings to consider this application

  • PASC meeting: 12 April 2017
  • ESC meeting: 5 October 2017
  • MSAC meeting: 
    • 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.