Response of Early Stage Breast Cancer to Chemotherapy Predicted

Australian women will have greater access to a genomic test that predicts whether patients with early-stage invasive breast cancer would benefit from chemotherapy.

Genomic Health's (Redwood City, CA, USA) Oncotype DX test is a 21-gene assay that predicts a patient’s likely benefit from chemotherapy as well as the overall risk of breast cancer recurrence. This technology guides treatment decisions, sparing patients the impact of unnecessary chemotherapy while identifying those patients who may benefit from additional treatment.

The Oncotype DX Breast Cancer Test is appropriate for recently diagnosed women with Stage I or II node-negative, estrogen-receptor-positive, HER2 negative, invasive breast cancer; and postmenopausal women with node-positive, hormone-receptor-positive, HER2 negative, invasive breast cancer. The Oncotype DX results are provided in the form of a Recurrence Score, a number between 0 and 100, which correlates to a specific likelihood of breast cancer recurrence within 10 years of chemotherapy.

Specialised Therapeutics Australia (STA; East Kew, Vic. Australia) will represent Oncotype DX Breast Cancer Assay from Genomic Health, a provider of genomic-based diagnostic tests that address both the overtreatment and optimal treatment of early stage cancer. The agreement with Genomic Health enables STA to distribute Oncotype DX in Australia and New Zealand. Under the terms of the agreement, STA will undertake all commercial operations including sales and marketing of the product within Australia as well as providing product support and practitioner education.

As part of the agreement, STA has partnered with Healthscope Pathology which will continue to oversee logistics in Australia, including tissue sample management.

Announcing the distribution agreement with Genomic Health, STA CEO Carlo Montagner said that the Oncotype DX assay was a high caliber tool for women diagnosed with early stage breast cancer who sought to avoid chemotherapy where possible, because it provided information about the likelihood of a cancer recurrence.

Carlo Montagner commented, "This ground breaking test, which has been universally adopted in the US, helps women make informed decisions." He added: "Many Australian women with early stage breast cancer have endured debilitating chemotherapy regimens as a precautionary measure. This test will arm women and their physicians with more information about the likelihood of the patient benefitting from chemotherapy, as well as recurrence, helping them make a well-informed treatment decision."

Developed by US-based Genomic Health, Oncotype DX has been evaluated in 15 clinical studies in more than 6,000 patients. These studies include a large validation study published in the New England Journal of Medicine (NEMJ) and a study published in the Journal of Clinical Oncology that examined whether Oncotype DX could predict the benefit of chemotherapy. Since becoming available in 2004, more than 400,000 Oncotype DX tests have been requested by more than 19,000 physicians in over 70 countries.

Related Links:
Genomic Health
Specialised Therapeutics Australia