1624 – 17p deletion testing for access to acalabrutinib in patients with previously untreated chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)

Amendment to existing MBS item (73343).

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. The high sensitivity and specificity of FISH and the speed with which the assays can be performed have made FISH a pivotal cytogenetic technique that has provided significant advances in both the research and diagnosis of haematological malignancies, including CLL.

Type: Investigative

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. SLL is essentially the same disease as CLL and is termed SLL when the cancer cells are located mainly in the lymph nodes.

• PASC meeting: -
• ESC meeting: -
• MSAC meeting: -