- 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 provision of ISH diagnostic test required to detect amplification of HER-2, a gene associated higher aggressiveness and poorer prognosis in breast cancer. A core or surgical biopsy of the tumor tissue is analysed for evidence of HER-2 over expression or positivity. Three types of ISH testing are used in Australia, these include: 1) fluorescent ISH; 2) chromogenic ISH; and 3) silver ISH.
Type: Co-dependent technology
Medical condition this application addresses
It is proposed that ISH diagnostic testing be made available to determine the HER-2 status of patients with advanced or metastatic breast cancer (stage IIIA-IV). The ISH diagnostic test will be used to identify patients that are likely to benefit from lapatinib treatment.
Application documents
PICO confirmation
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Meetings to consider this application
- PASC meeting:
- 1 – 2 December 2011
- 12 – 13 April 2012
- ESC meeting: -
- MSAC meeting: -