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Genomic Health Announces Presentation Of New Oncotype DXA® Studies Underscoring Unique Value Of The Test In Early-Stage Breast Cancer At The 36th Annual CTRC-AACR San Antonio Breast Cancer Symposium

REDWOOD CITY, Calif., Dec. 14, 2013 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced results from three studies of its Oncotype DX ® breast cancer test presented at the 36 th Annual CTRC-AACR San Antonio Breast Cancer Symposium (SABCS), reinforcing the unmatched value of the test to patients and physicians worldwide.  Oncotype DX remains the only genomic test to predict chemotherapy benefit, delivering clinically important and practice-changing information not provided by any other test.


"Ten years ago, the first validation study of the Oncotype DX assay was presented at SABCS, ushering in a new era of personalized breast cancer treatment," said Steven Shak, M.D., executive vice president of research and development, Genomic Health. "Over the last decade, in partnership with many collaborators, we have demonstrated that the rigorous validation of genomic information can transform cancer treatment.  Moving forward we will continue to apply our world-class science to lead the translation of massive amounts of genomic data into practice-changing results for treatment planning from screening and surveillance, through diagnosis, treatment selection and monitoring."

Fourth Head-to-Head Comparison Study to Show Oncotype DX Results Are Different from Tests Limited to Prognosis

A study examining three commercially available genomic tests evaluated if the information they provide is equivalent.  Specifically, results revealed a more than 44 percent discordance with other assays studied when compared to Oncotype DX, highlighting the potential to misclassify and mistreat patients if other assays are used to make a decision regarding chemotherapy treatment.   Oncotype DX is the only test included in treatment guidelines for both prognosis and the prediction of chemotherapy benefit and widely reimbursed by public and private payors for treatment decision making.

"As a clinical investigator and medical oncologist with a practice dedicated to breast cancer, I practice evidence-based medicine and therefore utilize genomic testing to gain an understanding of the breast tumor's individual biology to help guide critical treatment decisions," said Lori J. Goldstein, M.D., Fox Chase Cancer Center, Philadelphia, PA.  "If the question is whether or not to use chemotherapy, the answer is clear. To date, Oncotype DX is the only test that has been appropriately studied and validated to answer the specific question of which ER positive breast cancer patients need chemotherapy in addition to standard-of-care hormonal therapy."

Researchers conducting an analysis of 135 patient samples using Oncotype DX and a 70-gene prognostic test demonstrated that 33 percent of high-risk patients by the 70-gene assay were classified as low risk by the Oncotype DX Recurrence Score, indicating that these patients would likely receive no benefit from chemotherapy.  Further, five percent of the 70-gene assay low-risk patients were classified as high risk by the Oncotype DX test, indicating that they would likely have a significant, potentially life-saving benefit from chemotherapy. 

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