Genomic Health: Updated St. Gallen International Breast Cancer Guidelines Reinforce Important Role o

• Oncotype DX® test endorsed for guiding treatment decisions on adjuvant chemotherapy both in node-negative and in node-positive disease
• Gene expression signatures recommended for the first time as preferable to standard pathology, when adequate reproducibility is not granted

Genomic Health today announced that the 15th St. Gallen International Breast Cancer Conference Expert Panel endorsed the use of genomic tests in early-stage breast cancer and recognised the Oncotype DX Breast Recurrence Score® test for its prognostic ability as well as its value in guiding treatment decisions on adjuvant chemotherapy for patients with early-stage, endocrine sensitive, invasive breast cancer.

In particular, Oncotype DX® was the only test supported by a majority of panelists (58.6 percent) for its value in providing information that can help physicians "decide to omit chemotherapy" in patients with node positive disease (up to three nodes). The guidelines, which are reviewed bi-annually, have been recently published online in the Advance Access section of Annals of Oncology and will appear in a future print issue.

"We are pleased that this expert panel once again recognized the value of the Oncotype DX test. An extensive body of clinical evidence highlights the unique ability of our test to identify both patients who can be spared chemotherapy and – importantly - those who will clearly benefit from it, while providing a positive impact on healthcare systems," said Calvin Chao, Vice President of Global Medical Affairs at Genomic Health. "In addition to these updated guidelines, it is encouraging to see recently published data reinforcing that there is a spectrum of biology in breast cancer and growing evidence from all research groups on the importance of more precise estimates of risk and chemotherapy benefit as provided by the Oncotype DX individualized Recurrence Score result."

The Oncotype DX Breast Recurrence Score test is incorporated in all major international guidelines, including NICE, St. Gallen International Breast Cancer Expert Panel, ESMO, ASCO and NCCN. The test was also included in the 8th edition of the American Joint Committee on Cancer (AJCC) criteria for breast cancer staging, which will be effective in January 2018. This is particularly significant since AJCC has, for the first time, added molecular markers to staging criteria and identified Oncotype DX as the only gene test that can be used to determine formal staging of breast cancer patients along with hormonal status (ER, PR), and HER2 status.

Breast cancer is the most common cancer in European women(1) and affects many of them during their years dedicated to working and raising a family. While chemotherapy is routinely offered, research shows that less than 10 percent of patients with early-stage breast cancer actually benefit from it.(2)
The Oncotype DX test is designed to facilitate personalized clinical decisions by providing information about the biology of an individual breast cancer, with the potential to deliver financial benefits for healthcare systems. This is supported by substantial real-world evidence showing that the test can reduce the number of women undergoing unnecessary chemotherapy by up to 60 percent.(3)

About Oncotype DX
Oncotype DX is the only genomic test validated for its ability to predict the likelihood of chemotherapy benefit as well as risk of recurrence in early-stage breast cancer. Healthcare systems across Europe are recognizing the value of the test, which is incorporated in all major international clinical guidelines. Following assessment and recommendation by NICE, the Oncotype DX test is widely available to patients across the UK. In France, Oncotype DX is available through a funding mechanism for genomic tests. Other European countries where the test is reimbursed include Switzerland, Ireland, Greece and Spain.

About Genomic Health
Genomic Health, Inc. is a world’s leading provider of genomic-based diagnostic tests that address both the overtreatment and optimal treatment of cancer. With its Oncotype IQ® Genomic Intelligence Platform, the company is applying its state-of-the-art scientific and commercial expertise and infrastructure to translate significant amounts of genomic data into clinically-actionable results for treatment planning throughout the cancer patient's journey, from diagnosis to treatment selection and monitoring. The Oncotype IQ portfolio of genomic tests and services currently consists of the company's flagship line of Oncotype DX gene expression tests that have been used to guide treatment decisions for more than 750,000 cancer patients worldwide. Genomic Health is expanding its test portfolio to include additional liquid and tissue-based tests, including the recently launched Oncotype SEQ® Liquid Select™ test. The company is based in Redwood City, California with international headquarters  in Geneva, Switzerland.