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Oncotype DX Press Release re: AJCC Cancer Staging Manual

REDWOOD CITY, Calif., Dec. 22, 2016 /PRNewswire/ -- Genomic Health, Inc. (NASDAQ: GHDX) today announced that based on unparalleled clinical evidence, the American Joint Committee on Cancer (AJCC) incorporated the Oncotype DX® test in its recently published Eighth Edition AJCC Cancer Staging Manual. Representing a rigorous, multi-disciplinary assessment, the updated criteria identify Oncotype DX as the only multi-gene test with Level I evidence to determine formal staging of breast cancer patients, based on clinical evidence in more than 63,000 patients.

"For the first time, AJCC has added molecular signatures to complement the traditional anatomic features of the disease, transitioning cancer diagnosis and care to truly personalized medicine," said Steven Shak, M.D., chief scientific officer, Genomic Health. "We believe this groundbreaking milestone will enhance physicians' ability to deliver the excellent patient outcomes demonstrated across multiple prospective studies of the Oncotype DX test."

Effective January 2018, the new AJCC Prognostic Stage Groups will add the Oncotype DX Breast Recurrence Score™, hormonal status (ER, PR), and HER2 status to nodal status, tumor size, and tumor grade for staging breast cancer. For patients with node-negative disease or micrometastases in the nodes, a low Oncotype DX Recurrence Score (RS<11) classifies a patient as having the most favorable Prognostic Stage, regardless of tumor grade or tumor size (up to five centimeters).

As part of the implementation process, all AJCC partners, including the College of American Pathologists (CAP) and the National Comprehensive Cancer Network (NCCN), will develop and update protocols and tools to facilitate successful adoption of the required new staging system rules in 2018. The electronic version of the Eighth Edition AJCC Cancer Staging Manual is scheduled to be available the first quarter of 2017.

As stated in the AJCC publication1, "Based on the best available evidence at this time, the Expert Panel determined that it was appropriate to incorporate multigene molecular profiling to incorporate the Oncotype DX score into staging for the subgroup of patients defined by Arm A of the TAILORx study. These patients should be staged according to the AJCC Prognostic Stage Groups. The findings for the ODX (Oncotype DX) test are supported by Level I Evidence (large-scale prospective clinical trial data)."

The results of the Trial Assigning IndividuaLized Options for Treatment (Rx), or TAILORx, led by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) were published in The New England Journal of Medicine in 2015. Additionally, the Eighth Edition AJCC Cancer Staging Manual cites clinical outcomes data from tens of thousands of patients in the United States generated by the Surveillance, Epidemiology, and End Results (SEER) Registry program of the National Cancer Institute (NCI), demonstrating that patients with low Recurrence Scores have excellent breast cancer survival at five years.