Applications

1342.5 – Oncotype DX® breast cancer assay to quantify the risk of disease recurrence and predict adjuvant chemotherapy benefit (resubmission)

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 Re-application
  • Pre-PASC consultation -
  • Pre-MSAC consultation -
  • Outcome Not supported

Application details

Reason for application

Re-submission.

Service or technology in this application

Oncotype DX® is a genomic test that predicts likelihood of response to adjuvant chemotherapy and 10-year cancer recurrence in patients with node-negative and node positive (1–3), oestrogen-receptor-positive(ER+), human epidermal growth factor receptor 2 negative(HER2-), invasive breast cancer.

Type: Investigative

Medical condition this application addresses

Outside Australia, Oncotype DX® is currently used in women with node-negative and node positive (1-3), oestrogen-receptor-positive, HER2 negative invasive early stage breast cancer.

Previous applications

1342.4 – Oncotype DX? breast cancer assay to quantify the risk of disease recurrence and predict adjuvant chemotherapy benefit (Resubmission)
1342.3 – Oncotype DX? breast cancer assay to quantify the risk of disease recurrence and predict adjuvant chemotherapy benefit (Resubmission)
1342.2 – Oncotype DX? breast cancer assay to quantify the risk of disease recurrence and predict adjuvant chemotherapy benefit (Resubmission)
1342.1 – Oncotype DX? breast cancer assay to quantify the risk of disease recurrence and predict adjuvant chemotherapy benefit (Resubmission)
1342 – Gene expression profiling of 21 genes in breast cancer to quantify the risk of disease recurrence and predict adjuvant chemotherapy benefit

Application documents

Public summary document

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Meetings to consider this application

  • PASC meeting: -
  • ESC meeting: 13 June 2019
  • MSAC meeting: 1-2 August 2019

     

More information

Note: for PICO confirmation, refer to application 1342.