Oncotype DX® DCIS Score™ Represents Breakthrough in Personalizing Treatment of Pre-Invasive Breast Cancer

Genomic Health, Inc.

today announced positive results from the second large clinical validation study of Oncotype DX® in patients with a pre-invasive form of breast cancer known as DCIS (ductal carcinoma in situ). The study, conducted by the Ontario DCIS Study Group of Sunnybrook Health Sciences Centre in Canada, reconfirmed that the Oncotype DX DCIS Score™ is a strong predictor of local recurrence, which could be either invasive breast cancer or DCIS (p<0.001). "When a woman is diagnosed with DCIS, my goal as a physician is to accurately assess her individual risk for cancer returning so we can define and personalize an appropriate treatment plan with greater confidence," said Michael Alvarado, M.D., breast cancer surgeon, the University of California, San Francisco Helen Diller Family Comprehensive Cancer Center. "This landmark study analyzed an unprecedented collection of tissue samples and reconfirmed Oncotype DX as an objective biomarker that provides independent information beyond what has been available to physicians before, which can be seen as the biggest advancement in the management of DCIS in more than a decade." This largest genomic study in DCIS to date examined a broad, population-based cohort of more than 1,200 DCIS patient tumor samples collected from patients diagnosed with DCIS between 1994 and 2003 in Ontario, Canada. The primary analysis, presented at the 2014 San Antonio Breast Cancer Symposium (SABCS), included 571 patients who were treated with breast-conserving surgery where the tumor was completely removed. The results, which are consistent with those of the original ECOG-ACRIN Cancer Research group clinical validation study, demonstrated that the DCIS Score quantified the 10year risk of local recurrence beyond clinical factors such as tumor size and grade. This analysis clearly identified that the majority (62 percent) of studied DCIS patients were low risk based on the tumor biology revealed by the Oncotype DX test. "Sunnybrook's study marks a new era in personalized treatment for tens of thousands of women diagnosed with DCIS each year," said Frederick Baehner, M.D., vice president, Pathology, Genomic Health and assistant professor at the University of California, San Francisco. "We believe that the strength and breadth of these positive results will expand adoption of the Oncotype DX DCIS Score and provide further confidence to physicians and their patients as they include the test in making their treatment decisions." Separately, at SABCS Genomic Health presented positive results from its first liquid biopsy study demonstrating the company's ability to detect breast cancer in blood. Additional presentations included the first prospective outcomes data for the Oncotype DX breast cancer test from one of Europe's largest contemporary adjuvant breast cancer trials that was designed to evaluate anthracyline-free adjuvant chemotherapy and used the test to stratify patients according to their risk of recurrence.