1408.1 – A prognostic RT-qPCR test for prediction of risk of distant recurrence of breast cancer under endocrine treatment

New MBS item.

EndoPredict® comprises an in vitro test using RT-qPCR (reverse transcription quantitative real-time polymerase chain reaction) technology in combination with online software to analyse gene expression data. The software also incorporates clinical information (node status and tumour size) to calculate an EPclin score (on a continuous scale) to estimate a breast cancer patient’s risk of distant recurrence up to 10 years after surgery if treated with endocrine therapy only. RT-qPCR is conducted in a local laboratory under Australian regulatory standards using the EndoPredict® Kit manufactured by Myriad Genetics GmbH and distributed by Myriad Genetics Pty Ltd.

Type: Investigative technology

Breast cancer is the abnormal growth of cells lining the breast lobules (milk-producing glands) or breast ducts (passages that drain milk from the lobules towards the nipple), or in the fatty and fibrous tissue of the breast. EndoPredict® is proposed for patients with primary ER+/HER2– early-stage breast cancer. ER and HER2 describe the receptor subtype of breast cancer. ER+ breast cancers have receptors that allow them to use the hormone estrogen to grow. The HER2 protein promotes growth, and in some types of breast cancer is overproduced (HER2+). The receptor subtype of breast cancer can provide useful information on the patient’s prognosis and how the cells may respond to treatment. Endocrine therapy is used to block the action of the hormones that promote cancer growth.

• PASC meeting: Bypassed PASC
• ESC meeting: 9 – 10 June 2022
• MSAC meeting: 28 – 29 July 2022