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

Page last updated: 23 February 2022

Application Detail

Description of Medical Service

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.

Description of Medical Condition

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.

Reason for Application

New MBS item

Medical Service Type

Investigative technology

Previous Application Number/s

1408

Associated Documentation

Application Form

Application Form (PDF 1250 KB)
Application Form (Word 192 KB)

Consultation Survey

Consultation Survey (PDF 691 KB)
Consultation Survey (Word 72 KB)

PASC Consultation
Not applicable

MSAC Consultation
MSAC consultation input must be received by no later than Friday, 10 June 2022 for it to be considered by MSAC at its July 2022 meeting.

For further information please refer to PASC, ESC, MSAC Key Dates
For further information on the consultation process please refer to MSAC Consultation Process

PICO Confirmation

-

Assessment Report

-

Public Summary Document

-

Meetings for this Application

PASC

Bypassing PASC

ESC

9–10 June 2022

MSAC

28–29 July 2022