1607 – 17p deletion testing for access to acalabrutinib in patients with relapsed or refractory chronic lymphocytic leukaemia

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 Supported

Application details

Reason for application

Amendment to existing MBS item.

Service or technology in this application

Fluorescent in situ hybridization (FISH) is a molecular cytogenetic technique used to test the presence or absence of specific chromosome regions and is often used to detect chromosome deletions such as 17p. This involves using a specific DNA probe which recognises the region to be tested. The probe is labelled with a fluorescent dye and is hybridised to the chromosomes on a microscope slide. It will only stick to its matched region. In a normal cell this will give two signals (one from each chromosome) and in a cell with a deletion will give only one signal.

Type: Co-dependent technology

Medical condition this application addresses

Chronic lymphocytic leukaemia (CLL) is a life-threatening B-cell malignancy which originates in the bone marrow and results in abnormally high numbers of white blood cells. CLL is an incurable disease with conventional therapies, with its natural history being one of repeated relapse. CLL patients harbouring a 17p deletion have a particularly poor prognosis and generally respond poorly to many of the chemotherapeutic agents used to treat CLL.

Meetings to consider this application

  • PASC meeting: -
  • ESC meeting: -
  • MSAC meeting: 3 April 2020