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Results from five new studies on Genomic Health's Oncotype DX breast cancer test announced

Published on December 16, 2009 at 12:02 AM · No Comments

Genomic Health, Inc. (Nasdaq: GHDX) today announced results from five new studies on its Oncotype DX® breast cancer test, a multi-gene expression test that physicians currently use to predict the likelihood of chemotherapy benefit and recurrence risk for patients with early-stage breast cancer. These data were presented at the 32nd Annual CTRC-AACR San Antonio Breast Cancer Symposium, held December 9 - 13, 2009, in San Antonio, TX.

"The breadth of data presented at last week's meeting reflects our enduring commitment to provide physicians and their breast cancer patients with accurate and precise clinical information that can be used to make individualized treatment decisions," said Steven Shak, M.D., chief medical officer of Genomic Health. "We believe no other breast cancer test laboratory has demonstrated the reproducible clinical utility that Genomic Health has established with Oncotype DX, and we plan to continue to add value to the test through our ongoing research and clinical experience that includes more than 120,000 breast cancer patients."

Highlights from the five studies presented by Genomic Health and research collaborators include:

Oncotype DX Predicts Anthracycline-Based Chemotherapy Benefit in Women with ER+, N+ Breast Cancer

  • An analysis, presented as a late-breaking poster during a discussion on multigene assays on Thursday, December 10, reinforced the conclusion that chemotherapy does not appear to benefit patients with either 1-3 or 4 or more positive nodes for disease-free survival over 10 years, if their tumors have a low Recurrence Score® result. Researchers from Southwest Oncology Group (SWOG), a National Cancer Institute-supported clinical trials cooperative group, observed no breast cancer specific survival (BCSS) benefit from chemotherapy in either the low (log-rank>

Oncotype DX Leads to Fewer Recommendations of Chemotherapy for Women with Node-Positive Breast Cancer

  • A multi-institutional clinical survey presented on Friday, December 11 involving 160 physicians who currently use Oncotype DX in node-positive breast cancer patients found that treatment recommendations frequently changed based on Recurrence Score results, with an overall reduction in chemotherapy treatment recommendations. In the 138 patients with node-positive, hormone receptor-positive breast cancer where the physician had a specific treatment recommendation before obtaining the Oncotype DX Recurrence Score, recommended treatment changed from hormonal therapy plus chemotherapy to hormonal therapy alone in 46 patients (33%), and from hormonal therapy alone to hormonal therapy plus chemotherapy in 13 patients (9%) after obtaining the Recurrence Score.

Oncotype DX Can Be Successfully Performed on Breast Cancer Core Biopsy Samples, Suggesting Potential Role in Neoadjuvant Treatment Planning

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