- Guidelines Specify that Validated Molecular Assays Should be Considered as an Adjunct to Standard Measures in Helping Determine Chemotherapy Benefit -

GENEVA, and REDWOOD CITY, Calif., June 26 /PRNewswire-FirstCall/ -- Genomic Health, Inc. (Nasdaq: GHDX) today reported that the St. Gallen International Consensus Panel on the Primary Therapy of Early Breast Cancer recommended for the first time that validated multigene assays, such as Oncotype DX(R), should be considered as an adjunct to standard measures in helping determine chemotherapy benefit for early-stage breast cancer patients. These new treatment guidelines, published online in the cancer journal, Annals of Oncology, represent a significant advancement for the role of validated molecular diagnostics in breast cancer treatment planning and selection in Europe.

According to the guidelines, the threshold for recommending chemotherapy in treating estrogen receptor (ER) positive, HER2-negative breast cancer is difficult to define. Clinical research in the United States and other countries shows that information obtained from multigene assays, including Oncotype DX, leads to a change in treatment decisions in approximately 30 percent of cases. Physicians from more than 40 countries currently use Oncotype DX to predict the likelihood of chemotherapy benefit as well as the likelihood of recurrence for patients with early stage breast cancer, in order to make individualized treatment decisions about the addition of chemotherapy to hormonal therapy.

Oncotype DX was launched in the United States in 2004 where is has since been widely adopted as standard of care for treating early-stage breast cancer. Oncotype DX is the only validated multigene expression assay recommended in both the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) guidelines, and extensively reimbursed in the United States. To date, physicians have used Oncotype DX for breast cancer treatment planning in more than 100,000 patients in over 40 countries worldwide.

'We are pleased that the prestigious St. Gallen International Consensus recognizes the benefit that validated genomic tests, such as Oncotype DX, can offer to patients diagnosed with early stage breast cancer,' said Gary Palmer, Vice President of Medical Affairs, Genomic Health.