Genomic Health, Inc. reported that the St. Gallen International Consensus Panel on the Primary Therapy of Early Breast Cancer recommended its Oncotype DX as an adjunct to standard measures in helping determine chemotherapy benefit for early-stage breast cancer patients. These new treatment guidelines represent a significant advancement for the role of validated molecular diagnostics in breast cancer treatment planning and selection in Europe.

According to the guidelines it is difficult to define the threshold for recommending chemotherapy in treating estrogen receptor (ER) positive, HER2-negative breast cancer. Clinical research in the US and other countries shown that in approximately 30 percent of cases a change in treatment decisions is obtained from the information provided by multigene assays, including Oncotype DX. The Oncotype DX is used by physicians from more than 40 countries to predict the likelihood of chemotherapy benefit as well as the likelihood of recurrence for patients with early stage breast cancer.

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

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. We believe these guidelines support the expansion of Oncotype DX in the European market and should help establish favorable reimbursement policies, making our test readily available for physicians and patients in this important region.

The St. Gallen consensus guidelines are determined bi-annually by a panel of more than 30 breast cancer experts to provide evidence-based, scientifically valid recommendations for the treatment of early breast cancer. The European body of experts for the first time supported the use of a validated multigene-profiling assay as an adjunct to high-quality phenotyping of breast cancer in cases where the indication for adjuvant chemotherapy is uncertain.

These new guidelines provide further evidence that the international clinical community sees the value of advanced molecular diagnostics in helping make more informed, individualized breast cancer treatment decisions, said Dr. Joseph Gligorov, Tenon Hospital, Paris. More patients for whom the prognostic evaluation is still uncertain with the classical and optimal pathological tools, should now be offered the opportunity to benefit from these new tests, as it provides both physicians and patients with valuable, accurate information about their individual cancer and greater confidence in treatment selection.